Panels › Clinical Toxicology › Product code KLN · Class 2
Radioimmunoassay, Cocaine Metabolite
Regulation 862.3250
0510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KLN
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 4 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Immunalysis Corporation | 2 | 0 |
| V-Tech, Inc. | 2 | 0 |
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Icn Micromedic Systems | 1 | 0 |
| Psychemedics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2001 | K010868 | PSYCHEMEDICS RIA COCAINE ASSAY Psychemedics Corp. | KLN |
| Sep 19, 1991 | K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) Immunalysis Corporation | KLN |
| Sep 10, 1991 | K913722 | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE Roche Diagnostic Systems, Inc. | KLN |
| Jul 26, 1991 | K912756 | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE Roche Diagnostic Systems, Inc. | KLN |
| Mar 19, 1991 | K910123 | TARGET COCAINE METABOLITE-V V-Tech, Inc. | KLN |
| Mar 19, 1991 | K910122 | TARGET COCAINE METABOLITE-R V-Tech, Inc. | KLN |
| Feb 13, 1991 | K910044 | MILENIA COCAINE METABOLITE Diagnostic Products Corp. | KLN |
| Jan 15, 1991 | K905730 | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) Roche Diagnostic Systems, Inc. | KLN |
| Nov 28, 1990 | K904995 | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE Roche Diagnostic Systems, Inc. | KLN |
| Oct 6, 1988 | K880674 | MICROMEDIC CRACKPOT RIA KIT Icn Micromedic Systems | KLN |
| Jun 16, 1987 | K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] Immunalysis Corporation | KLN |
| Mar 19, 1987 | K870740 | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 Diagnostic Products Corp. | KLN |
| Jun 27, 1986 | K862218 | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT Diagnostic Products Corp. | KLN |
| Mar 24, 1983 | K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META Hoffmann-La Roche, Inc. | KLN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.