GSP Neonatal Creatine Kinase - MM kit— 510(k) DEN180056

Unknown

Perkinelmer, Inc.

FDA 510(k) clearance DEN180056 for GSP Neonatal Creatine Kinase - MM kit, Unknown on 2019-12-12. Applicant: Perkinelmer, Inc.. Device class: 2.

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code QJE
Device class: Class 2
Regulation: 21 CFR 862.1506
Advisory panel: Clinical Chemistry
Date received: 2018-10-11
Decision date: 2019-12-12
Decision: Unknown
Clearance type: Direct
Location: Waltham, MA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.