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FDA 510(k)

PHENYLALANINE TEST KIT

K-Number: K943547 · 1996-01-26

ApplicantIsolab, Inc.
Decision Date1996-01-26
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHENYLALANINE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K943547. 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 PHENYLALANINE TEST KIT?

PHENYLALANINE TEST KIT is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Isolab, Inc.. The 510(k) number is K943547.

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

PHENYLALANINE TEST KIT received FDA 510(k) clearance on 1996-01-26, under 510(k) number K943547.

Who is the listed applicant for PHENYLALANINE TEST KIT?

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

What is the FDA product code for PHENYLALANINE TEST KIT?

The FDA product code for PHENYLALANINE TEST KIT is JNB.

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Other records listing Isolab, Inc. 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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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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