ORTHO AUTOMATED CELL COUNTER— 510(k) K801545

Substantially Equivalent

Ortho Instruments

FDA 510(k) clearance K801545 for ORTHO AUTOMATED CELL COUNTER, Substantially Equivalent on 1980-09-09. Applicant: Ortho Instruments. Device class: 2.

Clearance details

Applicant: Ortho Instruments
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1980-07-07
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho Instruments

K803073 — ORTHO HEMATOLOGY CONTROL1980-12-31
K803083 — ORTHO HEMOTOLOGY CONTROL-NORMAL1980-12-31
K803084 — ORTHO HEMATOLOGY CONTROL ABNORMAL LOW1980-12-31
K802094 — ORTHO SPECTRUM1980-10-10
K781146 — HEMAC LASER HEMATOLOGY SYSTEM1978-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.