SALMONELLA & SHIGELLA GROUPING SERA
FDA 510(k) clearance K820996 · decided 1982-05-03
Clearance details
- K-number
- K820996
- Device name
- SALMONELLA & SHIGELLA GROUPING SERA
- Applicant
- Fisher Scientific Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 1982-04-09
- Decision date
- 1982-05-03
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- GRL
- Device class
- 2
- Regulation number
- 866.3550
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA (K945839) | Sa Scientific, Inc. | 1995-03-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001) | Fisher Scientific Co., LLC | 1979-07-18 |