HEMOHLOBIN A2 CONTROL-LYOPHILIZED— 510(k) K801410

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K801410 for HEMOHLOBIN A2 CONTROL-LYOPHILIZED, Substantially Equivalent on 1980-07-21. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 1980-06-16
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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