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FDA 510(k)

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

K-Number: K000754 · 2000-06-19

ApplicantQuantase , Ltd.
Decision Date2000-06-19
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quantase , Ltd.. It received FDA 510(k) clearance on 2000-06-19 under 510(k) number K000754. The device is classified under product code JNB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT?

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT is a medical device that received FDA 510(k) clearance on 2000-06-19. The listed applicant is Quantase , Ltd.. The 510(k) number is K000754.

When did QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT receive FDA 510(k) clearance?

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT received FDA 510(k) clearance on 2000-06-19, under 510(k) number K000754.

Who is the listed applicant for QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT?

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 PHENYLALANINE SCREENING ASSAY 500 TEST KIT?

The FDA product code for QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT is JNB.

Related Clinical Trials

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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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.

K990644QUANTASE TOTAL GALACTOSE SCREENING ASSAYK990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KITK984463QUANTASE PHE/GAL SCREENING ASSAY

Related Devices (Code: JNB)

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.

K021541NEOGRAM PKU TANDEM MASS SPECTROMETRY KITPerkinelmer Life SciencesK003584NEOLYNX SCREENING APPLICATION MANAGERMicromass, Inc.K984463QUANTASE PHE/GAL SCREENING ASSAYQuantase , Ltd.K982307WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000Wallac, Inc.K974047ACCUWELL PHENYLALANINE ASSAYNeometrics, Inc.K963040MANUAL PHENYLALANINE TESTBio-Rad

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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