FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K991010 |
ABBOTT DIAGNOSTICS MFG., INC. |
ACP |
05/19/1999 |
K840661 |
AMERICAN DADE |
PARAMAX ACID PHOSPHATASE REAGENT |
04/04/1984 |
K023840 |
BAYER DIAGNOSTICS CORP. |
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 |
01/07/2003 |
K053612 |
BECKMAN COULTER, INC. |
DRI-STAT ACID PHOSPHATASE REAGENT |
04/26/2006 |
K823087 |
BOEHRINGER MANNHEIM CORP. |
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA |
11/18/1982 |
K853949 |
COOPER BIOMEDICAL, INC. |
DEMAND ACID PHOSPHATASE REAGENT |
10/16/1985 |
K902543 |
CRESTAT DIAGNOSTICS, INC. |
ACID PHOSPHOTASE REAGENT TEST AND KIT |
09/07/1990 |
K861675 |
DATA MEDICAL ASSOCIATES, INC. |
ACID PHOSPHATASE PROCEDURE |
05/29/1986 |
K850902 |
DATA MEDICAL ASSOCIATES, INC. |
DATA ZYME ACID PHOSPHATASE PROCEDURE |
03/20/1985 |
K875209 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
ACID PHOSPHATASE (KINETIC) CAT. # 320-06 |
02/01/1988 |
K820975 |
GILFORD DIAGNOSTICS |
GILCHEM ACID PHOSPHATASE REAGENT |
04/26/1982 |
K943366 |
INSTRUMENTATION LABORATORY CO. |
IL TEST ACID PHOSPHATASE |
01/29/1996 |
K854223 |
MARVIC INTERPHARMA, INC. |
VES-TEC/VES-MATIC |
04/04/1986 |
K892393 |
MEDICAL ANALYSIS SYSTEMS, INC. |
ACID PHOSPHATASE REAGENT |
07/20/1989 |
K963640 |
OLYMPUS AMERICA, INC. |
OLYMPUS ACID PHOSPHATASE REAGENT |
02/18/1997 |
K981743 |
OLYMPUS AMERICA, INC. |
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER |
06/09/1998 |
K831834 |
REAGENTS APPLICATIONS, INC. |
RAICHEM ACID PHASPHATASE REAGENT |
08/26/1983 |
K974695 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) |
05/21/1998 |
K881204 |
SCLAVO, INC. |
ACP KINETIC TEST (ACID PHOSPHATASE TEST) |
04/28/1988 |
K863851 |
SIGMA DIAGNOSTICS, INC. |
ACID PHOSPHATASE (ACP) REAGENT |
10/16/1986 |
K821674 |
SMITH KLINE DIAGNOSTICS, INC. |
SPINCHEM ACID PHOSPHATASE REAGENT |
06/22/1982 |
K902495 |
TECH INTL. CO. |
ACID PHOSPHATASE REAGENT SET |
07/16/1990 |
K884747 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) |
01/30/1989 |
K880798 |
TRACE AMERICA, INC. |
ACID PHOSPHATASE REAGENT |
04/18/1988 |