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510(k) K772105

PLATELET KIT by Streck Laboratories, Inc. — Product Code GLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1977
Date Received
November 7, 1977
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 Streck Laboratories, Inc.

  • K042587 — RETIC-CHEX FOR CELL-DYN (October 19, 2004)
  • K040107 — CYTO-CHEX BCT (July 27, 2004)
  • K040025 — A1C-CELLULAR (March 2, 2004)
  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K021922 — MODIFICATION TO PARA 5X (June 25, 2002)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K011410 — PARA 5X (June 26, 2001)
  • K001443 — SUGAR CHEX ONE (June 29, 2000)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)

Other clearances for product code GLG

  • K842921 — REES & ECKER DILUTION FLUID (September 7, 1984)
  • K811084 — LABTRONIX PLATELET COUNTER(L/O/C.) (July 23, 1981)