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FDA 510(k)

MANUAL PHENYLALANINE TEST

K-Number: K963040 · 1996-10-01

ApplicantBio-Rad
Decision Date1996-10-01
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MANUAL PHENYLALANINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1996-10-01 under 510(k) number K963040. 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 MANUAL PHENYLALANINE TEST?

MANUAL PHENYLALANINE TEST is a medical device that received FDA 510(k) clearance on 1996-10-01. The listed applicant is Bio-Rad. The 510(k) number is K963040.

When did MANUAL PHENYLALANINE TEST receive FDA 510(k) clearance?

MANUAL PHENYLALANINE TEST received FDA 510(k) clearance on 1996-10-01, under 510(k) number K963040.

Who is the listed applicant for MANUAL PHENYLALANINE TEST?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL PHENYLALANINE TEST?

The FDA product code for MANUAL PHENYLALANINE TEST is JNB.

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Other records listing Bio-Rad 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.

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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

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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