URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
FDA 510(k) clearance K950134 · decided 1995-03-21
Clearance details
- K-number
- K950134
- Device name
- URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-13
- Decision date
- 1995-03-21
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DLN
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wilmington, DE, 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 |
|---|---|---|
| ABUSCREEN ONLINE FOR COCAINE METABOLITE (K924113) | Roche Diagnostic Systems, Inc. | 1992-12-28 |
| HIM TEST COCAINE (K792429) | Tecknam, Inc. | 1979-12-07 |
| COCAINE KIT, TOXI-PAK (K760401) | J.T. Baker Chemical Co. | 1976-08-26 |
Recalls involving this device
No recalls on record reference this clearance.