510(k) K813342
- Device
- GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
- Applicant
- GAMMA BIOLOGICALS, INC.
- 510(k) number
- K813342
- Product code
- KSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-04
- Date received
- 1981-11-25
- Regulation
- 864.9400
- Classification name
- Solution, Stabilized Enzyme
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3017237798
- 1034569
- 9681576
- 3016014873
- 9610824
- 3006261638
- 3011683976
- 3004910133
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813404 | FREEZE DRIED FICIN | Biological Corp. of America | 1982-02-10 |
| K810803 | FREEZE DRIED PAPAIN | Biological Corp. of America | 1981-07-21 |
| K780962 | AUTOMATED ENZYME | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| K760123 | AUTOZYME | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Legacy Summary#
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FDA Review#
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