510(k) K892241
- Device
- FETAL HEMOGLOBIN
- Applicant
- SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
- 510(k) number
- K892241
- Product code
- GHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-17
- Date received
- 1989-03-22
- Regulation
- 864.7455
- Classification name
- Stain, Fetal Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- QUINCY E CRIDER,PHD
- Address
- 11012 Lin Valle Dr., Suite D St. Louis MO US 63123 63123
FDA Registration Numbers#
- 1938095
- 1000138378
- 1938173
- 1950226
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990641 | CALTAG FETAL HEMOGLOBIN TEST | Caltag Laboratories, Inc. | 1999-09-17 |
Legacy Summary#
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FDA Review#
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