TRI-COUNT LASER— 510(k) K843485

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K843485 for TRI-COUNT LASER, Substantially Equivalent on 1984-12-12. Applicant: Hematology Marketing Assoc.. Device class: 2.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-09-06
Decision date: 1984-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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