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FDA 510(k)

QUANTASE PHENYLALANINE ASSAY

K-Number: K922547 · 1994-10-13

ApplicantPorton Cambridge , Ltd.
Decision Date1994-10-13
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTASE PHENYLALANINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Porton Cambridge , Ltd.. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K922547. 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 ASSAY?

QUANTASE PHENYLALANINE ASSAY is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Porton Cambridge , Ltd.. The 510(k) number is K922547.

When did QUANTASE PHENYLALANINE ASSAY receive FDA 510(k) clearance?

QUANTASE PHENYLALANINE ASSAY received FDA 510(k) clearance on 1994-10-13, under 510(k) number K922547.

Who is the listed applicant for QUANTASE PHENYLALANINE ASSAY?

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

What is the FDA product code for QUANTASE PHENYLALANINE ASSAY?

The FDA product code for QUANTASE PHENYLALANINE ASSAY is JNB.

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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.K984463QUANTASE PHE/GAL SCREENING ASSAYQuantase , Ltd.K982307WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000Wallac, Inc.K974047ACCUWELL PHENYLALANINE ASSAYNeometrics, 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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