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FDA 510(k)

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

K-Number: K982307 · 1999-02-02

ApplicantWallac, Inc.
Decision Date1999-02-02
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Wallac, Inc.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K982307. 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 WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000?

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Wallac, Inc.. The 510(k) number is K982307.

When did WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 receive FDA 510(k) clearance?

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 received FDA 510(k) clearance on 1999-02-02, under 510(k) number K982307.

Who is the listed applicant for WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000?

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

What is the FDA product code for WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000?

The FDA product code for WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 is JNB.

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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.K974047ACCUWELL PHENYLALANINE ASSAYNeometrics, 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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