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FDA 510(k)

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN

K-Number: K790710 · 1979-08-03

ApplicantKent Laboratories, Inc.
Decision Date1979-08-03
Product CodeDDY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K790710. The device is classified under product code DDY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN?

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K790710.

When did ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN receive FDA 510(k) clearance?

ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN received FDA 510(k) clearance on 1979-08-03, under 510(k) number K790710.

Who is the listed applicant for ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN?

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

What is the FDA product code for ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN?

The FDA product code for ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN is DDY.

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Other records listing Kent Laboratories, 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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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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