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FDA 510(k)

GAMMA FETAL BLEED SCREENING TEST

K-Number: K820647 · 1982-05-12

ApplicantGamma Biologicals, Inc.
Decision Date1982-05-12
Product CodeLIM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMMA FETAL BLEED SCREENING TEST 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 1982-05-12 under 510(k) number K820647. The device is classified under product code LIM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA FETAL BLEED SCREENING TEST?

GAMMA FETAL BLEED SCREENING TEST is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K820647.

When did GAMMA FETAL BLEED SCREENING TEST receive FDA 510(k) clearance?

GAMMA FETAL BLEED SCREENING TEST received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820647.

Who is the listed applicant for GAMMA FETAL BLEED SCREENING TEST?

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 FETAL BLEED SCREENING TEST?

The FDA product code for GAMMA FETAL BLEED SCREENING TEST is LIM.

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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 PREGNANCYK820072FE-CULT PLUSK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK811752FE-CULT PLUS

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Related Devices (Code: LIM)

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.

K980314FETAL D TECTION KITBiopool Intl., 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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