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510(k) K811084

LABTRONIX PLATELET COUNTER(L/O/C.) by Labtronix Corp. — Product Code GLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
April 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platelet Counting, Manual
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

Other clearances by Labtronix Corp.

  • K812031 — LPC II (August 12, 1981)

Other clearances for product code GLG

  • K842921 — REES & ECKER DILUTION FLUID (September 7, 1984)
  • K772105 — PLATELET KIT (November 30, 1977)