CALTAG FETAL HEMOGLOBIN TEST
FDA 510(k) clearance K990641 · decided 1999-09-17
Clearance details
- K-number
- K990641
- Device name
- CALTAG FETAL HEMOGLOBIN TEST
- Applicant
- Caltag Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-26
- Decision date
- 1999-09-17
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- GHQ
- Device class
- 2
- Regulation number
- 864.7455
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Dowingtown, PA, 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 |
|---|---|---|
| FETAL HEMOGLOBIN (K892241) | Sure-Tech Diagnostic Associates, Inc. | 1989-05-17 |
Recalls involving this device
No recalls on record reference this clearance.