HEMOGASTAT
FDA 510(k) clearance K801148 · decided 1980-06-09
Clearance details
- K-number
- K801148
- Device name
- HEMOGASTAT
- Applicant
- Therapac, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-13
- Decision date
- 1980-06-09
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JRR
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| DADE CHILL TRAY (K822132) | American Dade | 1982-08-05 |
| KRYORACK/4 (K780757) | Streck Laboratories, Inc. | 1978-06-06 |
| AQUAMATIC K-MODULE MODEL K-10 (K761337) | Gorman Rupp Industries | 1977-01-10 |
Recalls involving this device
No recalls on record reference this clearance.