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FDA 510(k)

FLOR. CONJUG. HUMAN FAB FRAGMENT

K-Number: K770670 · 1977-04-28

ApplicantKent Laboratories, Inc.
Decision Date1977-04-28
Product CodeDFK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLOR. CONJUG. HUMAN FAB FRAGMENT 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 1977-04-28 under 510(k) number K770670. The device is classified under product code DFK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOR. CONJUG. HUMAN FAB FRAGMENT?

FLOR. CONJUG. HUMAN FAB FRAGMENT is a medical device that received FDA 510(k) clearance on 1977-04-28. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K770670.

When did FLOR. CONJUG. HUMAN FAB FRAGMENT receive FDA 510(k) clearance?

FLOR. CONJUG. HUMAN FAB FRAGMENT received FDA 510(k) clearance on 1977-04-28, under 510(k) number K770670.

Who is the listed applicant for FLOR. CONJUG. HUMAN FAB FRAGMENT?

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 FLOR. CONJUG. HUMAN FAB FRAGMENT?

The FDA product code for FLOR. CONJUG. HUMAN FAB FRAGMENT is DFK.

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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: DFK)

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.

K790711ANTISERA TO HUMAN FRAGMENTKent Laboratories, Inc.K771243ANTISERA TO HUMAN FAB FRAGMENTKent 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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