PLATELET COUNTER & HEMATOCRIT ACCES.— 510(k) K771353

Name: FDA 510(k) clearance K771353
Creator: U.S. Food and Drug Administration
Published: 1977-08-10

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K771353 for PLATELET COUNTER & HEMATOCRIT ACCES., Substantially Equivalent on 1977-08-10. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1977-07-22
Decision date: 1977-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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