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NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

DEN040002 Class II Post-NSE
Decision Date
2004-08-24
Sponsor / Applicant
Perkinelmer Life Sciences, Inc.

Technical Specification

510(k) Submission ID DEN040002
Product Code NQL
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1055
Decision Date 2004-08-24
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 received FDA 510(k) clearance under submission number DEN040002, sponsored by Perkinelmer Life Sciences, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-08-24.

Classification & Regulation

This clearance is catalogued under FDA product code NQL and 21 CFR 862.1055, within the Clinical Chemistry review panel as a Class II device.