HIM TEST COCAINE
FDA 510(k) clearance K792429 · decided 1979-12-07
Clearance details
- K-number
- K792429
- Device name
- HIM TEST COCAINE
- Applicant
- Tecknam, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-28
- Decision date
- 1979-12-07
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- DLN
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (K950134) | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| ABUSCREEN ONLINE FOR COCAINE METABOLITE (K924113) | Roche Diagnostic Systems, Inc. | 1992-12-28 |
| COCAINE KIT, TOXI-PAK (K760401) | J.T. Baker Chemical Co. | 1976-08-26 |
Recalls involving this device
No recalls on record reference this clearance.