JM-102 JAUNDICE METER— 510(k) K972309

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K972309 for JM-102 JAUNDICE METER, Substantially Equivalent on 1998-09-22. Applicant: Air-Shields, Inc.. Device class: 1.

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 1997-06-20
Decision date: 1998-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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