PG-NUMERIC(TM)— 510(k) K883411

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K883411 for PG-NUMERIC(TM), Substantially Equivalent on 1989-03-15. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JHF
Device class: Class 2
Regulation: 21 CFR 862.1455
Advisory panel: Clinical Chemistry
Date received: 1988-08-15
Decision date: 1989-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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