SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA
FDA 510(k) clearance K945839 · decided 1995-03-07
Clearance details
- K-number
- K945839
- Device name
- SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA
- Applicant
- Sa Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-30
- Decision date
- 1995-03-07
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- GRL
- Device class
- 2
- Regulation number
- 866.3550
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Antonio, TX, 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 |
|---|---|---|
| SALMONELLA & SHIGELLA GROUPING SERA (K820996) | Fisher Scientific Co., LLC | 1982-05-03 |
Recalls involving this device
No recalls on record reference this clearance.