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FDA 510(k)

HYGEIA GC TEST

K-Number: K881064 · 1988-06-02

ApplicantHygeia Sciences
Decision Date1988-06-02
Product CodeLIR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HYGEIA GC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia Sciences. It received FDA 510(k) clearance on 1988-06-02 under 510(k) number K881064. The device is classified under product code LIR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGEIA GC TEST?

HYGEIA GC TEST is a medical device that received FDA 510(k) clearance on 1988-06-02. The listed applicant is Hygeia Sciences. The 510(k) number is K881064.

When did HYGEIA GC TEST receive FDA 510(k) clearance?

HYGEIA GC TEST received FDA 510(k) clearance on 1988-06-02, under 510(k) number K881064.

Who is the listed applicant for HYGEIA GC TEST?

The FDA 510(k) record lists Hygeia Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYGEIA GC TEST?

The FDA product code for HYGEIA GC TEST is LIR.

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Other records listing Hygeia Sciences 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.

K882192HYGEIA URINE PREGNANCY TESTK862083HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAYK862133HYGEIA RAPID STREP A TEST

Related Devices (Code: LIR)

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.

K023947GC OIAThermo Biostar, Inc.K882534ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROLAbbott Laboratories

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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