Panels › Clinical Toxicology › Product code DKC · Class 1
Alcohol Control Materials
Regulation 862.3280
0510(k)s in 12 months (11 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
Top companies in DKC
| Company | 510(k)s | Recalls |
|---|---|---|
| Ameditech Inc | 0 | 5 |
| Cala Diagnostics | 2 | 0 |
| Sigma Diagnostics, Inc. | 2 | 0 |
| Syva Co. | 2 | 0 |
| Beckman-Diagnostic Systems Group | 1 | 0 |
| Columbia Diagnostics, Inc. | 1 | 0 |
| Fisher Diagnostics | 1 | 0 |
| Medical Analysis Systems, Inc. | 1 | 0 |
| Sigma Chemical Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2003 | K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL Medical Analysis Systems, Inc. | DKC |
| Mar 22, 1994 | K935819 | QUALITY CONTROL MATERIAL (ASSAYED) Columbia Diagnostics, Inc. | DKC |
| Nov 16, 1993 | K933425 | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 Sigma Diagnostics, Inc. | DKC |
| Oct 27, 1993 | K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL Beckman-Diagnostic Systems Group | DKC |
| Jun 16, 1993 | K932067 | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III Sigma Diagnostics, Inc. | DKC |
| Aug 12, 1991 | K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 Cala Diagnostics | DKC |
| Jul 26, 1991 | K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 Cala Diagnostics | DKC |
| Oct 31, 1984 | K843872 | ETHANOL CONTROLS LOW & HIGH E5133/E5258 Sigma Chemical Co. | DKC |
| Dec 8, 1983 | K833514 | TOXI CHEM SERUM ALCOHOL CONTROL Fisher Diagnostics | DKC |
| Mar 6, 1981 | K810465 | EMIT-ST ETHYL ALCOHOL SERUM CONTROLS Syva Co. | DKC |
| Oct 31, 1980 | K802618 | EMIT-STM ETHYL ALCOHOL URINE CONTROLS Syva Co. | DKC |
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