510(k) K913722
- Device
- Abuscreen(r) Radioimmun For Cocaine Metabolite
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K913722
- Product code
- KLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-10
- Date received
- 1991-08-16
- Regulation
- 862.3250
- Classification name
- Radioimmunoassay, Cocaine Metabolite
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KLN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | Psychemedics Corp. | 2001-11-06 |
| K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-19 |
| K912756 | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1991-07-26 |
| K910122 | TARGET COCAINE METABOLITE-R | V-Tech, Inc. | 1991-03-19 |
| K910123 | TARGET COCAINE METABOLITE-V | V-Tech, Inc. | 1991-03-19 |
| K910044 | MILENIA COCAINE METABOLITE | Diagnostic Products Corp. | 1991-02-13 |
| K905730 | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) | Roche Diagnostic Systems, Inc. | 1991-01-15 |
| K904995 | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1990-11-28 |
| K880674 | MICROMEDIC CRACKPOT RIA KIT | Icn Micromedic Systems | 1988-10-06 |
| K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | Immunalysis Corporation | 1987-06-16 |
| K870740 | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 | Diagnostic Products Corp. | 1987-03-19 |
| K862218 | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT | Diagnostic Products Corp. | 1986-06-27 |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Hoffmann-La Roche, Inc. | 1983-03-24 |