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FDA 510(k)

PHE/TYR KINETIC UV TEST SET

K-Number: K813449 · 1981-12-31

ApplicantP-L Biochemicals, Inc.
Decision Date1981-12-31
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHE/TYR KINETIC UV TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is P-L Biochemicals, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813449. 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 PHE/TYR KINETIC UV TEST SET?

PHE/TYR KINETIC UV TEST SET is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is P-L Biochemicals, Inc.. The 510(k) number is K813449.

When did PHE/TYR KINETIC UV TEST SET receive FDA 510(k) clearance?

PHE/TYR KINETIC UV TEST SET received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813449.

Who is the listed applicant for PHE/TYR KINETIC UV TEST SET?

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

What is the FDA product code for PHE/TYR KINETIC UV TEST SET?

The FDA product code for PHE/TYR KINETIC UV TEST SET is JNB.

Related Clinical Trials

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Other records listing P-L Biochemicals, 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.

K800517TOBRAM E.R.A. TM

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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