FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K832457 |
ABBOTT LABORATORIES |
A-GENT PHENOBARBITAL |
09/12/1983 |
K081231 |
ABBOTT LABORATORIES |
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 |
09/26/2008 |
K833796 |
ABBOTT LABORATORIES |
CHEM KIT PHENOBARBITAL |
01/30/1984 |
K860365 |
ALLIED INSTRUMENTATION LABORATORY |
PHENOBARBITAL TEST SYSTEM |
03/17/1986 |
K935568 |
BAXTER DIAGNOSTICS, INC. |
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS |
03/11/1994 |
K802039 |
BECKMAN INSTRUMENTS, INC. |
PHENOBARBITAL REAGENT TEST KIT |
10/23/1980 |
K860046 |
CLINICAL DATA, INC. |
DETERMINATION OF PHENOBARBITAL |
01/22/1986 |
K000012 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 |
03/03/2000 |
K946210 |
DIAGNOSTIC REAGENTS, INC. |
PHENOBARBITAL ENZYME IMMUNOASSAY |
02/10/1995 |
K944932 |
DUPONT MEDICAL PRODUCTS |
PHENOBARBITAL FLEX REAGENT CARTRIDGE |
12/28/1994 |
K770919 |
E.I. DUPONT DE NEMOURS & CO., INC. |
PHENOBARBITAL ANALYTICAL TEST PACKS |
06/22/1977 |
K862308 |
EM DIAGNOSTIC SYSTEMS, INC. |
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 |
07/07/1986 |
K864926 |
EM DIAGNOSTIC SYSTEMS, INC. |
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 |
01/07/1987 |
K852995 |
IMMUNOTECH CORP. |
ENDAB PHENOBARBITAL |
08/12/1985 |
K910355 |
INSTRUMENTATION LABORATORY CO. |
IL PHENOBARBITAL ASSAY SYSTEM |
04/03/1991 |
K943981 |
INSTRUMENTATION LABORATORY CO. |
IL TEST PHENOBARBITAL CALIBRATORS |
01/18/1995 |
K811367 |
KALLESTAD LABORATORIES, INC. |
KALLESTAD ANTISERA TO PHENOBARBITAL |
05/29/1981 |
K123271 |
MICROGENICS CORP. |
ABBOTT PHENOBARBITAL ASSAY |
04/26/2013 |
K852946 |
MILES LABORATORIES, INC. |
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT |
09/30/1985 |
K984288 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS PHBR SLIDES |
01/26/1999 |
K896861 |
PB DIAGNOSTIC SYSTEMS, INC. |
OPUS PHENOBARBITAL TEST SYSTEM |
01/11/1990 |
K011303 |
RANDOX LABORATORIES, LTD. |
RANDOX PHENOBARBITAL |
07/02/2001 |
K071644 |
ROCHE DIAGNOSTICS CORP. |
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 |
09/12/2007 |
K942501 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE CEDIA PHENOBARBITAL ASSAY |
10/06/1994 |
K993031 |
SYVA CO. |
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 |
01/27/2000 |
K854607 |
SYVA CO. |
ACCULEVEL PHENOBARBITAL TEST |
08/25/1986 |
K011528 |
SYVA CO. |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
06/06/2001 |
K874625 |
SYVA CO. |
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY |
12/22/1987 |
K834216 |
SYVA CO. |
EMIT QST PHENOBARBITAL ASSAY |
01/24/1984 |
K913190 |
SYVA CO. |
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS |
08/26/1991 |
K811621 |
SYVA CO. |
EMIT-ST SERUM PHENOBARBITAL ASSAY |
06/25/1981 |
K832097 |
SYVA CO. |
PHENOBARTIAL ASSAY USE ON COBAS-BIO |
08/11/1983 |
K884419 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON RA-PHENOBARBITAL |
11/22/1988 |
K842264 |
VENTREX LABORATORIES, INC. |
VENTREZYME PHENOBARBITAL KIT IMMUNO |
08/14/1984 |