PLATELET AGITATOR— 510(k) K812533

Substantially Equivalent

Helmer Labs, Inc.

FDA 510(k) clearance K812533 for PLATELET AGITATOR, Substantially Equivalent on 1981-09-29. Applicant: Helmer Labs, Inc.. Device class: 1.

Clearance details

Applicant
Helmer Labs, Inc.
Product code
Code KSQ
Device class
Class 1
Regulation
21 CFR 864.9195
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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