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FDA 510(k)

BIO-RAD CODA NEONATAL GALT ASSAY

K-Number: K993536 · 1999-11-04

ApplicantBio-Rad
Decision Date1999-11-04
Product CodeKQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD CODA 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 1999-11-04 under 510(k) number K993536. 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 BIO-RAD CODA NEONATAL GALT ASSAY?

BIO-RAD CODA NEONATAL GALT ASSAY is a medical device that received FDA 510(k) clearance on 1999-11-04. The listed applicant is Bio-Rad. The 510(k) number is K993536.

When did BIO-RAD CODA NEONATAL GALT ASSAY receive FDA 510(k) clearance?

BIO-RAD CODA NEONATAL GALT ASSAY received FDA 510(k) clearance on 1999-11-04, under 510(k) number K993536.

Who is the listed applicant for BIO-RAD CODA 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 BIO-RAD CODA NEONATAL GALT ASSAY?

The FDA product code for BIO-RAD CODA 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.K990827MICROPLATE 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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