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FDA 510(k)

MICROPLATE NEONATAL GALT ASSAY

K-Number: K990827 · 1999-04-09

ApplicantBio-Rad
Decision Date1999-04-09
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROPLATE NEONATAL GALT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-04-09 under 510(k) number K990827. The device is classified under product code KQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPLATE NEONATAL GALT ASSAY?

MICROPLATE NEONATAL GALT ASSAY is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Bio-Rad. The 510(k) number is K990827.

When did MICROPLATE NEONATAL GALT ASSAY receive FDA 510(k) clearance?

MICROPLATE NEONATAL GALT ASSAY received FDA 510(k) clearance on 1999-04-09, under 510(k) number K990827.

Who is the listed applicant for MICROPLATE NEONATAL GALT ASSAY?

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

What is the FDA product code for MICROPLATE NEONATAL GALT ASSAY?

The FDA product code for MICROPLATE NEONATAL GALT ASSAY is KQP.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: KQP)

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.

K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITAstoria-Pacific, Inc.K101392NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DAstoria-Pacific, Inc.K100101GSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.K993536BIO-RAD CODA NEONATAL GALT ASSAYBio-RadK970277URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)Astoria-Pacific, Inc.K894011TOTAL GALACTOSEAlpkem Corp.

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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