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FDA 510(k)

QUANTASE PHE/GAL SCREENING ASSAY

K-Number: K984463 · 1999-02-16

ApplicantQuantase , Ltd.
Decision Date1999-02-16
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTASE PHE/GAL 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 1999-02-16 under 510(k) number K984463. 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 PHE/GAL SCREENING ASSAY?

QUANTASE PHE/GAL SCREENING ASSAY is a medical device that received FDA 510(k) clearance on 1999-02-16. The listed applicant is Quantase , Ltd.. The 510(k) number is K984463.

When did QUANTASE PHE/GAL SCREENING ASSAY receive FDA 510(k) clearance?

QUANTASE PHE/GAL SCREENING ASSAY received FDA 510(k) clearance on 1999-02-16, under 510(k) number K984463.

Who is the listed applicant for QUANTASE PHE/GAL 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 PHE/GAL SCREENING ASSAY?

The FDA product code for QUANTASE PHE/GAL SCREENING ASSAY 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.

K000754QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KITK990644QUANTASE TOTAL GALACTOSE SCREENING ASSAYK990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

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.K000754QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KITQuantase , 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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