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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B Terminated |
DKC | K052115 |
| Aug 18, 2020 | Ameditech Inc ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description):
PSD-6MB/ "ProScreen" Drugs of Abuse Test
(MET1000/OPI2000)+AMP+BZO+COC+THC",
PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test
(COC/THC)+BZO Terminated |
DKC | K052115 K113046 |
| Aug 18, 2020 | Ameditech Inc MicroTox (AMT Item Number/ AMT Description):
MTPA-6MBAU / "MicroTox
(AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300)
With Cr, Ni, pH, Bl, S.G.",
MTPA-6MBAU/ "MicroTox
(AMP300/BZO200)+(COC300/THC50) Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc MicroScreen (AMT Item Number/ AMT Description):
MSCA-6MBAU/ "MicroScreen
AMP300/BZO200/COC300/MET300/OPI300/ THC50
with Cr, Ni, pH, Bl, S.G. " Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description):
IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup
AMP1000+BZO300+COC300+OPI2000+THC50
With Cr, Ni, pH, Bl, S.G.",
IMC-8BBCE/ "ImmuTest Drugs Terminated |
DKC | K052115 K113046 |
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