HELENA HEMOGLOBIN F CONTROLS
FDA 510(k) clearance K810475 · decided 1981-03-26
Clearance details
- K-number
- K810475
- Device name
- HELENA HEMOGLOBIN F CONTROLS
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-02-23
- Decision date
- 1981-03-26
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- KQI
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| HBF DILUENT (K880653) | Helena Laboratories | 1988-04-21 |
| HELENA HBF QUIPLATE CONTROL (K812226) | Helena Laboratories | 1981-09-01 |
| SICKLE-CELL F TEST (K791143) | Isolab, Inc. | 1979-07-17 |
Recalls involving this device
No recalls on record reference this clearance.