DIALBUMIN— 510(k) K891544

Substantially Equivalent

Exocell, Inc.

FDA 510(k) clearance K891544 for DIALBUMIN, Substantially Equivalent on 1989-06-09. Applicant: Exocell, Inc.. Device class: 1.

Clearance details

Applicant: Exocell, Inc.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1989-03-17
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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