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510(k) K943268

SCS-1000 (SYSMEX CALIBRATOR SYSTEM) by Streck Laboratories, Inc. — Product Code KSA

K943268 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "SCS-1000 (SYSMEX CALIBRATOR SYSTEM)". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code KSA (Calibrator For Red-Cell And White-Cell Counting), a Class II device regulated under 21 CFR 864.8185. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
July 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Red-Cell And White-Cell Counting
Device Class
Class II
Regulation Number
864.8185
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 KSA

  • K897060 — CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE (January 2, 1990)
  • K881161 — TECH-CAL(TM)/MULTIPLE (May 2, 1988)
  • K864664 — H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (February 6, 1987)
  • K854823 — CBC-CAL/MULTIPLE (February 13, 1986)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K813530 — HEMOTOLOGY CALIBRATOR (February 22, 1982)
  • K813375 — HEMATOLOGY CALIBRATOR S-CAL (February 4, 1982)

FDA data resources