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FDA 510(k)

GAMMA PI BLOOD GROUP SUBSTANCE

K-Number: K802534 · 1980-11-12

ApplicantGamma Biologicals, Inc.
Decision Date1980-11-12
Product CodeKSX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMMA PI BLOOD GROUP SUBSTANCE 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 1980-11-12 under 510(k) number K802534. The device is classified under product code KSX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA PI BLOOD GROUP SUBSTANCE?

GAMMA PI BLOOD GROUP SUBSTANCE is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K802534.

When did GAMMA PI BLOOD GROUP SUBSTANCE receive FDA 510(k) clearance?

GAMMA PI BLOOD GROUP SUBSTANCE received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802534.

Who is the listed applicant for GAMMA PI BLOOD GROUP SUBSTANCE?

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 PI BLOOD GROUP SUBSTANCE?

The FDA product code for GAMMA PI BLOOD GROUP SUBSTANCE is KSX.

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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 TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUS

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Related Devices (Code: KSX)

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.

K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K800916P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.K781895BLOOD GROUP SUBSTANCE BNorth American Biologicals, Inc.K781896BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.K771488P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.

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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