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FDA 510(k)

PHENYLALANINE (NINHYDRIN REACTION)

K-Number: K891070 · 1989-10-27

ApplicantAlpkem Corp.
Decision Date1989-10-27
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHENYLALANINE (NINHYDRIN REACTION) is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K891070. 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 (NINHYDRIN REACTION)?

PHENYLALANINE (NINHYDRIN REACTION) is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Alpkem Corp.. The 510(k) number is K891070.

When did PHENYLALANINE (NINHYDRIN REACTION) receive FDA 510(k) clearance?

PHENYLALANINE (NINHYDRIN REACTION) received FDA 510(k) clearance on 1989-10-27, under 510(k) number K891070.

Who is the listed applicant for PHENYLALANINE (NINHYDRIN REACTION)?

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

What is the FDA product code for PHENYLALANINE (NINHYDRIN REACTION)?

The FDA product code for PHENYLALANINE (NINHYDRIN REACTION) is JNB.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.K890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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