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510(k) K770830

PLATELET AGITATOR by Helmer Labs, Inc. — Product Code GLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
May 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Blood Tube
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Helmer Labs, Inc.

  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)

Other clearances for product code GLE

  • K823124 — IMS HEMATOLOGY MIXER (November 22, 1982)
  • K800003 — CORTEX DOUBLE HELIX SAMPLER (February 1, 1980)
  • K780544 — DISC-PAK ROTATOR (April 24, 1978)
  • K771617 — SPECI-MIX (September 2, 1977)