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FDA 510(k)

QUANTASE TOTAL GALACTOSE SCREENING ASSAY

K-Number: K990644 · 1999-06-21

ApplicantQuantase , Ltd.
Decision Date1999-06-21
Product CodeJIA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTASE TOTAL GALACTOSE SCREENING ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quantase , Ltd.. It received FDA 510(k) clearance on 1999-06-21 under 510(k) number K990644. The device is classified under product code JIA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTASE TOTAL GALACTOSE SCREENING ASSAY?

QUANTASE TOTAL GALACTOSE SCREENING ASSAY is a medical device that received FDA 510(k) clearance on 1999-06-21. The listed applicant is Quantase , Ltd.. The 510(k) number is K990644.

When did QUANTASE TOTAL GALACTOSE SCREENING ASSAY receive FDA 510(k) clearance?

QUANTASE TOTAL GALACTOSE SCREENING ASSAY received FDA 510(k) clearance on 1999-06-21, under 510(k) number K990644.

Who is the listed applicant for QUANTASE TOTAL GALACTOSE SCREENING ASSAY?

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

What is the FDA product code for QUANTASE TOTAL GALACTOSE SCREENING ASSAY?

The FDA product code for QUANTASE TOTAL GALACTOSE SCREENING ASSAY is JIA.

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Other records listing Quantase , Ltd. 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.

K000754QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KITK990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KITK984463QUANTASE PHE/GAL SCREENING ASSAY

Related Devices (Code: JIA)

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.

K190335GSP Neonatal Total Galactose kitPerkinelmer, Inc.K121101SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITAstoria-Pacific, Inc.K071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BWallac OYK990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KITQuantase , Ltd.K991498ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGALNeometrics, Inc.K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITIsolab, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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