DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
FDA 510(k) clearance K931474 · decided 1994-05-10
Clearance details
- K-number
- K931474
- Device name
- DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
- Applicant
- Gbf Medical Group
- Decision
- Unknown
- Date received
- 1993-03-24
- Decision date
- 1994-05-10
- Days to decision
- 412 days
- Clearance type
- Traditional
- Product code
- KDW
- Device class
- 1
- Regulation number
- 864.3250
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Greensboro, NC, 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 |
|---|---|---|
| SASI-DC1TS (K970580) | Substance Abuse Specialties, Inc. | 1997-04-17 |
| CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122) | Harry A. Schlakman | 1995-05-05 |
| DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (K913967) | Doxtech, Inc. | 1991-10-18 |
Recalls involving this device
No recalls on record reference this clearance.