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FDA 510(k)

GAMMA ARACHIS HYPOGEA LECTIN

K-Number: K792583 · 1980-01-16

ApplicantGamma Biologicals, Inc.
Decision Date1980-01-16
Product CodeKSI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMMA ARACHIS HYPOGEA LECTIN 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 1980-01-16 under 510(k) number K792583. The device is classified under product code KSI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA ARACHIS HYPOGEA LECTIN?

GAMMA ARACHIS HYPOGEA LECTIN is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K792583.

When did GAMMA ARACHIS HYPOGEA LECTIN receive FDA 510(k) clearance?

GAMMA ARACHIS HYPOGEA LECTIN received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792583.

Who is the listed applicant for GAMMA ARACHIS HYPOGEA LECTIN?

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 ARACHIS HYPOGEA LECTIN?

The FDA product code for GAMMA ARACHIS HYPOGEA LECTIN is KSI.

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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: KSI)

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.

K820368LECTIN-AAmerican DadeK813413LECTIN HAmerican DadeK792582POLY-LEC SYSTEMGamma Biologicals, 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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