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FDA 510(k)

ANTI-GM & ANTI-KM TYPING SERUMS

K-Number: K812076 · 1981-08-12

ApplicantBiotest-Serum-Institut
Decision Date1981-08-12
Product CodeDGH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-GM & ANTI-KM TYPING SERUMS is the device name listed in this FDA 510(k) record. The listed applicant is Biotest-Serum-Institut. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K812076. The device is classified under product code DGH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-GM & ANTI-KM TYPING SERUMS?

ANTI-GM & ANTI-KM TYPING SERUMS is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Biotest-Serum-Institut. The 510(k) number is K812076.

When did ANTI-GM & ANTI-KM TYPING SERUMS receive FDA 510(k) clearance?

ANTI-GM & ANTI-KM TYPING SERUMS received FDA 510(k) clearance on 1981-08-12, under 510(k) number K812076.

Who is the listed applicant for ANTI-GM & ANTI-KM TYPING SERUMS?

The FDA 510(k) record lists Biotest-Serum-Institut as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-GM & ANTI-KM TYPING SERUMS?

The FDA product code for ANTI-GM & ANTI-KM TYPING SERUMS is DGH.

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Other records listing Biotest-Serum-Institut 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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