Home / 510(k) Clearances / K761086

510(k) K761086

REAGENTS by Simmler & Son, Inc. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1977
Date Received
November 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type

Other clearances by Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760473 — REAGENT, ALBUMIN DETERMINATION (October 29, 1976)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760475 — REAGENT, CALCIUM DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)

Other clearances for product code JJC

  • K945915 — AVL OMNI ANALYZER (April 5, 1995)
  • K945584 — NOVA 16 ANALYZER (February 8, 1995)
  • K943376 — OPERA SYSTEM (September 14, 1994)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (April 9, 1990)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (November 15, 1988)
  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)