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510(k) K780544

DISC-PAK ROTATOR by Techhnilab Instruments, Inc. — Product Code GLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1978
Date Received
April 3, 1978
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 Techhnilab Instruments, Inc.

  • K813523 — ELECTRIC SELF STERILIZATION INOCUL. LOOP (December 31, 1981)
  • K780543 — THERMAJUST CIRCU-TEMP (May 26, 1978)
  • K771434 — MULTI-CAVITY EQUILIBRIUM CELL (August 22, 1977)
  • K770169 — BEESON AUTOMADDAK FEEDER (January 28, 1977)
  • K770170 — MADDATHERM PARAFFIN BATH (January 28, 1977)

Other clearances for product code GLE

  • K823124 — IMS HEMATOLOGY MIXER (November 22, 1982)
  • K800003 — CORTEX DOUBLE HELIX SAMPLER (February 1, 1980)
  • K771617 — SPECI-MIX (September 2, 1977)
  • K770830 — PLATELET AGITATOR (July 11, 1977)