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FDA 510(k)

ANTI-HUMAN SERUM

K-Number: K791282 · 1979-10-17

ApplicantDiagnostica, Inc.
Decision Date1979-10-17
Product CodeDGQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-HUMAN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791282. The device is classified under product code DGQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-HUMAN SERUM?

ANTI-HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Diagnostica, Inc.. The 510(k) number is K791282.

When did ANTI-HUMAN SERUM receive FDA 510(k) clearance?

ANTI-HUMAN SERUM received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791282.

Who is the listed applicant for ANTI-HUMAN SERUM?

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

What is the FDA product code for ANTI-HUMAN SERUM?

The FDA product code for ANTI-HUMAN SERUM is DGQ.

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Other records listing Diagnostica, 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.

K002756EASE-A-CULTK823348H. INFLUENZA B ANTISERA FOR CIEK812434DIAGNOSTIC KITS & KIT COMPONENTSK800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTK791283ANTI-HUMAN LAMBDA SERUMK791284ANTI-HUMAN KAPPA SERUM

View all 12 devices →

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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