TRYPSIN 1%
FDA 510(k) clearance K771955 · decided 1977-11-22
Clearance details
- K-number
- K771955
- Device name
- TRYPSIN 1%
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-17
- Decision date
- 1977-11-22
- Days to decision
- 36 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 |
|---|---|---|
| SPUTASOL (K802493) | Oxoid U.S.A., Inc. | 1980-11-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |