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510(k) K040107

CYTO-CHEX BCT by Streck Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2004
Date Received
January 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Streck Laboratories, Inc.

  • K042587 — RETIC-CHEX FOR CELL-DYN (October 19, 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)
  • K000115 — RETIC CHEX LINEARITY (March 27, 2000)

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  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)