FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K934467 |
BECKMAN-DIAGNOSTIC SYSTEMS GROUP |
BECKMAN CX AMMONIA/ALCOHOL CONTROL |
10/27/1993 |
K912827 |
CALA DIAGNOSTICS |
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 |
08/12/1991 |
K912826 |
CALA DIAGNOSTICS |
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 |
07/26/1991 |
K935819 |
COLUMBIA DIAGNOSTICS, INC. |
QUALITY CONTROL MATERIAL (ASSAYED) |
03/22/1994 |
K833514 |
FISHER DIAGNOSTICS |
TOXI CHEM SERUM ALCOHOL CONTROL |
12/08/1983 |
K031392 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL |
07/01/2003 |
K843872 |
SIGMA CHEMICAL CO. |
ETHANOL CONTROLS LOW & HIGH E5133/E5258 |
10/31/1984 |
K933425 |
SIGMA DIAGNOSTICS, INC. |
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 |
11/16/1993 |
K932067 |
SIGMA DIAGNOSTICS, INC. |
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III |
06/16/1993 |
K810465 |
SYVA CO. |
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS |
03/06/1981 |
K802618 |
SYVA CO. |
EMIT-STM ETHYL ALCOHOL URINE CONTROLS |
10/31/1980 |