TOTAL HEMOGLOBIN— 510(k) K863104

Substantially Equivalent

J. D. Assoc.

FDA 510(k) clearance K863104 for TOTAL HEMOGLOBIN, Substantially Equivalent on 1986-09-04. Applicant: J. D. Assoc.. Device class: 2.

Clearance details

Applicant: J. D. Assoc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1986-08-14
Decision date: 1986-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

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