510(k) K990641
- Device
- CALTAG FETAL HEMOGLOBIN TEST
- Applicant
- CALTAG LABORATORIES, INC.
- 510(k) number
- K990641
- Product code
- GHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-09-17
- Date received
- 1999-02-26
- Regulation
- 864.7455
- Classification name
- Stain, Fetal Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID C BISHOP
- Address
- 605 Dilworth Rd. Dowingtown PA US 19335 19335
FDA Registration Numbers#
- 1938095
- 1000138378
- 1938173
- 1950226
Source Documents#
Other 510(k) Records For Product Code GHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892241 | FETAL HEMOGLOBIN | Sure-Tech Diagnostic Associates, Inc. | 1989-05-17 |
Legacy Summary#
summary
FDA Review#
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