STAPHYLOCOCCAL PROTEIN A INSOLUBLE
FDA 510(k) clearance K812181 · decided 1981-08-25
Clearance details
- K-number
- K812181
- Device name
- STAPHYLOCOCCAL PROTEIN A INSOLUBLE
- Applicant
- Oxoid U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-03
- Decision date
- 1981-08-25
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LHJ
- Device class
- 1
- Regulation number
- 866.3700
- 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 |
|---|---|---|
| STAPHYTECT-OD (K940557) | Unipath , Ltd. | 1994-07-28 |
| IMMUSTAPH LATEX AGGLUTINATION KIT (K842709) | Immucell Corp. | 1984-08-03 |
Recalls involving this device
No recalls on record reference this clearance.