SPUTASOL
FDA 510(k) clearance K802493 · decided 1980-11-12
Clearance details
- K-number
- K802493
- Device name
- SPUTASOL
- Applicant
- Oxoid U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-10
- Decision date
- 1980-11-12
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- IBG
- Device class
- 1
- Regulation number
- 864.4400
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| TRYPSIN 1% (K771955) | Flow Laboratories, Inc. | 1977-11-22 |
Recalls involving this device
No recalls on record reference this clearance.