Gamma Chloroquine Diphosphate Solution
FDA 510(k) K813342 · Gamma Biologicals, Inc.
510(k) numberK813342
Submission
- Device name
- Gamma Chloroquine Diphosphate Solution
- Applicant
- Gamma Biologicals, Inc.
Walker, MI, US - Received
- November 25, 1981
- Decision date
- March 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSK – Solution, Stabilized Enzyme
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9400
- Specialty
- Hematology
Other 510(k)s with product code KSK
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|---|---|---|---|
| K813404 | Freeze Dried FicinKSK · Traditional | Biological Corp. of America | 02/10/1982SE |
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| K780962 | Automated EnzymeKSK · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 07/27/1978SE |
| K760123 | AutozymeKSK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1976SE |
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Questions and answers
When was Gamma Chloroquine Diphosphate Solution cleared by the FDA?
Gamma Chloroquine Diphosphate Solution (K813342) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 99 days after the submission was received.
What is the product code of K813342?
The FDA product code is KSK – Solution, Stabilized Enzyme, a Class II (moderate risk) device regulated under 21 CFR 864.9400.