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FDA 510(k)

POLY-LEC SYSTEM

K-Number: K792582 · 1980-01-16

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

Device Summary

POLY-LEC SYSTEM 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 K792582. 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 POLY-LEC SYSTEM?

POLY-LEC SYSTEM 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 K792582.

When did POLY-LEC SYSTEM receive FDA 510(k) clearance?

POLY-LEC SYSTEM received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792582.

Who is the listed applicant for POLY-LEC SYSTEM?

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 POLY-LEC SYSTEM?

The FDA product code for POLY-LEC SYSTEM 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 DadeK792583GAMMA ARACHIS HYPOGEA LECTINGamma 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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