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510(k) K801897

GLUCOSE DIAGNOSTIC REAGENT by Connecticut Diagnostics, Ltd. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Connecticut Diagnostics, Ltd.

  • K905617 — VISI-STAPH (March 29, 1991)
  • K822504 — CDL AUTO-LYSING REAGENT (September 17, 1982)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K801898 — URIC ACID DIAGNOSTIC REAGENT (October 10, 1980)
  • K792465 — CONNECTICUT DIAGNOSTICS, LTS. DIRECT (December 18, 1979)
  • K792339 — CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K792340 — CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (December 6, 1979)

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