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FDA 510(k)

ANTISERUM TO HUMAN PREALBUMIN

K-Number: K850686 · 1985-11-01

ApplicantKent Laboratories, Inc.
Decision Date1985-11-01
Product CodeJZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN PREALBUMIN 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 1985-11-01 under 510(k) number K850686. The device is classified under product code JZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM TO HUMAN PREALBUMIN?

ANTISERUM TO HUMAN PREALBUMIN is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K850686.

When did ANTISERUM TO HUMAN PREALBUMIN receive FDA 510(k) clearance?

ANTISERUM TO HUMAN PREALBUMIN received FDA 510(k) clearance on 1985-11-01, under 510(k) number K850686.

Who is the listed applicant for ANTISERUM TO HUMAN PREALBUMIN?

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 PREALBUMIN?

The FDA product code for ANTISERUM TO HUMAN PREALBUMIN is JZJ.

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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: JZJ)

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.

K000661RANDOX PREALBUMINRandox Laboratories, Ltd.K972638TINA-QUANT PREALBUMINBoehringer Mannheim Corp.K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic AntibodiesK884297SPQ(TM) TEST SYSTEM FOR PREALBUMINAtlantic Antibodies

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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