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510(k) K883503

COULTER VISCOMETER II by Coulter Electronics, Inc. — Product Code JJL

K883503 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "COULTER VISCOMETER II". The FDA issued a decision of Substantially Equivalent on September 19, 1988. The device falls under product code JJL (Plasma Viscometer For Clinical Use), a Class I device regulated under 21 CFR 862.2920. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1988
Date Received
August 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma Viscometer For Clinical Use
Device Class
Class I
Regulation Number
862.2920
Review Panel
CH
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)

FDA data resources