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510(k) K792101

COUITER/CMS ISOTONIC BLOOD BANK SALINE by Coulter Electronics, Inc. — Product Code JCE

K792101 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "COUITER/CMS ISOTONIC BLOOD BANK SALINE". The FDA issued a decision of Substantially Equivalent on November 20, 1979. The device falls under product code JCE (Solution, Isotonic), a Class I device regulated under 21 CFR 864.4010. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1979
Date Received
October 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Isotonic
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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 JCE

  • K842722 — BUFFERED SALINE (September 11, 1984)
  • K831200 — IMMUNOHEMATOLOGICAL SALINE #97139 (May 9, 1983)
  • K801506 — CERTIFIED BLOOD BANK SALINE (July 28, 1980)
  • K761183 — LYSING AGENT AF (January 17, 1977)
  • K761174 — PHYSIOLOGIC SALINE (0.85%) (January 10, 1977)
  • K761170 — BARBITAL SALINE BUFFER (January 10, 1977)

FDA data resources