URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
FDA 510(k) clearance K950182 · decided 1995-03-21
Clearance details
- K-number
- K950182
- Device name
- URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1995-03-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- DIW
- Device class
- 2
- Regulation number
- 862.3620
- 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 |
|---|---|---|
| ROCHE ABUSCREEN ONTRAK FOR METHADONE (K930845) | Roche Diagnostic Systems, Inc. | 1993-04-20 |
| HI-M-TEST FOR METHADONE TEST #2 (K801509) | Technam, Inc. | 1980-07-14 |
| KIT, METHADONE (TOXI-PAK IMMUNO HI) (K760075) | J.T. Baker Chemical Co. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.