ORTHO HEMOTOLOGY CONTROL-NORMAL— 510(k) K803083

Name: FDA 510(k) clearance K803083
Creator: U.S. Food and Drug Administration
Published: 1980-12-31

Substantially Equivalent

Ortho Instruments

FDA 510(k) clearance K803083 for ORTHO HEMOTOLOGY CONTROL-NORMAL, Substantially Equivalent on 1980-12-31. Applicant: Ortho Instruments. Device class: 2.

Clearance details

Applicant: Ortho Instruments
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-12-05
Decision date: 1980-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K801545 — ORTHO AUTOMATED CELL COUNTER1980-09-09
K781146 — HEMAC LASER HEMATOLOGY SYSTEM1978-09-14

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