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FDA 510(k)

PREALBUMIN ENZYME IMMUNOASSAY

K-Number: K821135 · 1983-05-05

ApplicantAbbott Laboratories
Decision Date1983-05-05
Product CodeJZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PREALBUMIN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-05-05 under 510(k) number K821135. 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 PREALBUMIN ENZYME IMMUNOASSAY?

PREALBUMIN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is Abbott Laboratories. The 510(k) number is K821135.

When did PREALBUMIN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

PREALBUMIN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1983-05-05, under 510(k) number K821135.

Who is the listed applicant for PREALBUMIN ENZYME IMMUNOASSAY?

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

What is the FDA product code for PREALBUMIN ENZYME IMMUNOASSAY?

The FDA product code for PREALBUMIN ENZYME IMMUNOASSAY is JZJ.

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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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