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510(k) K781601

TEKNI-CAL by Streck Laboratories, Inc. — Product Code KRY

K781601 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "TEKNI-CAL". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code KRY (Calibrator For Platelet Counting), a Class II device regulated under 21 CFR 864.8175. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Platelet Counting
Device Class
Class II
Regulation Number
864.8175
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 KRY

  • K862122 — S-CAL HEMATOLOGY CALIBRATOR (May 20, 1987)
  • K852016 — LASER PLATELETCAL/MULTIPLE (July 9, 1985)
  • K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR (January 7, 1985)
  • K840794 — S-CAL HEMATOLOGY CALIBRATOR (April 4, 1984)
  • K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL (September 2, 1982)
  • K781133 — PC-CALIBRATOR (August 14, 1978)
  • K770143 — TQC CALIBRATION REFERENCE FOR PLATELETS (January 30, 1978)

FDA data resources