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GSP Neonatal Creatine Kinase - MM kit

DEN180056 Class II Direct
Decision Date
2019-12-12
Sponsor / Applicant
Perkinelmer, Inc.

Technical Specification

510(k) Submission ID DEN180056
Product Code QJE
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1506
Decision Date 2019-12-12
Clearance Pathway Direct

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

GSP Neonatal Creatine Kinase - MM kit received FDA 510(k) clearance under submission number DEN180056, sponsored by Perkinelmer, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2019-12-12.

Classification & Regulation

This clearance is catalogued under FDA product code QJE and 21 CFR 862.1506, within the Clinical Chemistry review panel as a Class II device.