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FDA 510(k)

ANTISERUM TO HUMAN IG G FC FRAGMENTS

K-Number: K790708 · 1979-08-22

ApplicantKent Laboratories, Inc.
Decision Date1979-08-22
Product CodeDAS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN IG G FC FRAGMENTS 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 1979-08-22 under 510(k) number K790708. The device is classified under product code DAS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM TO HUMAN IG G FC FRAGMENTS?

ANTISERUM TO HUMAN IG G FC FRAGMENTS is a medical device that received FDA 510(k) clearance on 1979-08-22. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K790708.

When did ANTISERUM TO HUMAN IG G FC FRAGMENTS receive FDA 510(k) clearance?

ANTISERUM TO HUMAN IG G FC FRAGMENTS received FDA 510(k) clearance on 1979-08-22, under 510(k) number K790708.

Who is the listed applicant for ANTISERUM TO HUMAN IG G FC FRAGMENTS?

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 IG G FC FRAGMENTS?

The FDA product code for ANTISERUM TO HUMAN IG G FC FRAGMENTS is DAS.

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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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Related Devices (Code: DAS)

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.

K982023PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KITInova Diagnostics, Inc.K944876HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITResearch Diagnostics, Inc.K943098HUMAN IGG SUBCLASSES ELISA COMBI KITResearch Diagnostics, Inc.K943205HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)Research Diagnostics, Inc.K895600HUMAN (IGG) SUBCLASS (EIA) KITThe Binding Site, Ltd.K790715ANTISERUM TO HUMAN FCKent Laboratories, 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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