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510(k) K813375

HEMATOLOGY CALIBRATOR S-CAL by Coulter Electronics, Inc. — Product Code KSA

K813375 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "HEMATOLOGY CALIBRATOR S-CAL". The FDA issued a decision of Substantially Equivalent on February 4, 1982. 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. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
December 1, 1981
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 Coulter Electronics, Inc.

  • K923951 — CD8 CYTOSPHERES KIT (April 25, 1994)
  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K922704 — COULTER MAXM W/ AUTOLOADER (July 27, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)

Other clearances for product code KSA

  • K943268 — SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (December 15, 1994)
  • 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)

FDA data resources