PLATELET AGITATOR— 510(k) K770830

Substantially Equivalent

Helmer Labs, Inc.

FDA 510(k) clearance K770830 for PLATELET AGITATOR, Substantially Equivalent on 1977-07-11. Applicant: Helmer Labs, Inc.. Device class: 1.

Clearance details

Applicant: Helmer Labs, Inc.
Product code: Code GLE
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1977-05-06
Decision date: 1977-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K771617 — SPECI-MIX1977-09-02

More clearances from Helmer Labs, Inc.

K812533 — PLATELET AGITATOR1981-09-29
K802608 — HEMATIC BLOOD MIXER1980-12-11

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