FETAL HEMOGLOBIN
FDA 510(k) clearance K892241 · decided 1989-05-17
Clearance details
- K-number
- K892241
- Device name
- FETAL HEMOGLOBIN
- Applicant
- Sure-Tech Diagnostic Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-22
- Decision date
- 1989-05-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GHQ
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| CALTAG FETAL HEMOGLOBIN TEST (K990641) | Caltag Laboratories, Inc. | 1999-09-17 |
Recalls involving this device
No recalls on record reference this clearance.