Panels › Clinical Toxicology › Product code DJG · Class 2
Enzyme Immunoassay, Opiates
Regulation 862.3650
3510(k)s in 12 months (215 all time)
2recalls in 12 months (13 all time)
9recalls that name a 510(k)
Top companies in DJG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 1988 | K882496 | ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE Roche Diagnostic Systems, Inc. | DJG |
| Aug 2, 1988 | K881941 | EMIT HVA OPIATE ASSAY Syva Co. | DJG |
| Feb 18, 1988 | K874808 | COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 Diagnostic Products Corp. | DJG |
| Feb 11, 1988 | K880010 | REVISED LABELING FOR ADX OPIATES Abbott Laboratories | DJG |
| Nov 23, 1987 | K874485 | REVISED LABELING FOR OPIATES Abbott Laboratories | DJG |
| Nov 13, 1987 | K874268 | REVISED LABELING FOR MORPHINE TEST KIT Roche Diagnostic Systems, Inc. | DJG |
| Oct 29, 1987 | K873898 | REVISED LABELING FOR SYVA OPIATE ASSAYS Syva Co. | DJG |
| Oct 15, 1987 | K873758 | LABELING CHANGE COAT-A-COUNT SERUM MORPHINE Diagnostic Products Corp. | DJG |
| Oct 15, 1987 | K873757 | LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE Diagnostic Products Corp. | DJG |
| Aug 10, 1987 | K872391 | ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD E.I. Dupont DE Nemours & Co., Inc. | DJG |
| Jun 15, 1987 | K871698 | RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] Immunalysis Corporation | DJG |
| Nov 25, 1985 | K854421 | TDX R OPIATES Abbott Laboratories | DJG |
| Sep 26, 1984 | K842677 | EMIT D.A.U. OPIATE ASSAY Syva Co. | DJG |
| Sep 14, 1984 | K843162 | EMIT 700 OPIATE ASSAY Syva Co. | DJG |
| Jan 26, 1984 | K833581 | MODIF. OF EMIT URINE OPIATE ASSAY Syva Co. | DJG |
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