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FDA 510(k)

ACCUWELL PHENYLALANINE ASSAY

K-Number: K974047 · 1997-12-05

ApplicantNeometrics, Inc.
Decision Date1997-12-05
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUWELL PHENYLALANINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K974047. 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 ACCUWELL PHENYLALANINE ASSAY?

ACCUWELL PHENYLALANINE ASSAY is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Neometrics, Inc.. The 510(k) number is K974047.

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

ACCUWELL PHENYLALANINE ASSAY received FDA 510(k) clearance on 1997-12-05, under 510(k) number K974047.

Who is the listed applicant for ACCUWELL PHENYLALANINE ASSAY?

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

What is the FDA product code for ACCUWELL PHENYLALANINE ASSAY?

The FDA product code for ACCUWELL PHENYLALANINE ASSAY is JNB.

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Other records listing Neometrics, Inc. as applicant

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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.K963040MANUAL PHENYLALANINE TESTBio-Rad

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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