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FDA 510(k)

TINA-QUANT PREALBUMIN

K-Number: K972638 · 1998-01-09

ApplicantBoehringer Mannheim Corp.
Decision Date1998-01-09
Product CodeJZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT PREALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K972638. 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 TINA-QUANT PREALBUMIN?

TINA-QUANT PREALBUMIN is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K972638.

When did TINA-QUANT PREALBUMIN receive FDA 510(k) clearance?

TINA-QUANT PREALBUMIN received FDA 510(k) clearance on 1998-01-09, under 510(k) number K972638.

Who is the listed applicant for TINA-QUANT PREALBUMIN?

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

What is the FDA product code for TINA-QUANT PREALBUMIN?

The FDA product code for TINA-QUANT PREALBUMIN is JZJ.

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Other records listing Boehringer Mannheim Corp. 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.

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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.K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K913672PREALBUMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K884297SPQ(TM) TEST SYSTEM FOR PREALBUMINAtlantic AntibodiesK884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic AntibodiesK883002QM300 PREALBUMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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