HBF DILUENT
FDA 510(k) clearance K880653 · decided 1988-04-21
Clearance details
- K-number
- K880653
- Device name
- HBF DILUENT
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1988-02-17
- Decision date
- 1988-04-21
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KQI
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, 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 |
|---|---|---|
| HELENA HBF QUIPLATE CONTROL (K812226) | Helena Laboratories | 1981-09-01 |
| HELENA HEMOGLOBIN F CONTROLS (K810475) | Helena Laboratories | 1981-03-26 |
| SICKLE-CELL F TEST (K791143) | Isolab, Inc. | 1979-07-17 |
Recalls involving this device
No recalls on record reference this clearance.