ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
FDA 510(k) clearance K913722 · decided 1991-09-10
Clearance details
- K-number
- K913722
- Device name
- ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-16
- Decision date
- 1991-09-10
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KLN
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Montclair, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PSYCHEMEDICS RIA COCAINE ASSAY (K010868) | Psychemedics Corp. | 2001-11-06 |
| URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867) | Immunalysis Corporation | 1991-09-19 |
| ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756) | Roche Diagnostic Systems, Inc. | 1991-07-26 |
| TARGET COCAINE METABOLITE-R (K910122) | V-Tech, Inc. | 1991-03-19 |
| TARGET COCAINE METABOLITE-V (K910123) | V-Tech, Inc. | 1991-03-19 |
| MILENIA COCAINE METABOLITE (K910044) | Diagnostic Products Corp. | 1991-02-13 |
| ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (K905730) | Roche Diagnostic Systems, Inc. | 1991-01-15 |
| ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (K904995) | Roche Diagnostic Systems, Inc. | 1990-11-28 |
| MICROMEDIC CRACKPOT RIA KIT (K880674) | Icn Micromedic Systems | 1988-10-06 |
| RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (K871549) | Immunalysis Corporation | 1987-06-16 |
| COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 (K870740) | Diagnostic Products Corp. | 1987-03-19 |
| DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT (K862218) | Diagnostic Products Corp. | 1986-06-27 |
Recalls involving this device
No recalls on record reference this clearance.