COUNTER 700 & HC-700 HEMO 0 REF.— 510(k) K771107

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K771107 for COUNTER 700 & HC-700 HEMO 0 REF., Substantially Equivalent on 1977-07-11. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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