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FDA 510(k)

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION

K-Number: K813342 · 1982-03-04

ApplicantGamma Biologicals, Inc.
Decision Date1982-03-04
Product CodeKSK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K813342. The device is classified under product code KSK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION?

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K813342.

When did GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION receive FDA 510(k) clearance?

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION received FDA 510(k) clearance on 1982-03-04, under 510(k) number K813342.

Who is the listed applicant for GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION?

The FDA 510(k) record lists Gamma Biologicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION?

The FDA product code for GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION is KSK.

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Other records listing Gamma Biologicals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK820072FE-CULT PLUSK811752FE-CULT PLUS

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Related Devices (Code: KSK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K813404FREEZE DRIED FICINBiological Corp. of AmericaK810803FREEZE DRIED PAPAINBiological Corp. of AmericaK780962AUTOMATED ENZYMEHyland Therapeutic Div., Travenol LaboratoriesK760123AUTOZYMEBd Becton Dickinson Vacutainer Systems Preanalytic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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