SASI-DC1TS
FDA 510(k) clearance K970580 · decided 1997-04-17
Clearance details
- K-number
- K970580
- Device name
- SASI-DC1TS
- Applicant
- Substance Abuse Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-14
- Decision date
- 1997-04-17
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KDW
- Device class
- 1
- Regulation number
- 864.3250
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Research Triangle Park, 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 |
|---|---|---|
| CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122) | Harry A. Schlakman | 1995-05-05 |
| DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (K931474) | Gbf Medical Group | 1994-05-10 |
| DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (K913967) | Doxtech, Inc. | 1991-10-18 |
Recalls involving this device
No recalls on record reference this clearance.