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510(k) K921825

QUICK-CHECK II REAGENT STRIP by Diagnostic Solutions, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1992
Date Received
April 16, 1992
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 Diagnostic Solutions, Inc.

  • K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION (January 11, 1994)
  • K924398 — UNI-CHECK REAGENT STRIP (December 23, 1992)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800679 — REAGENTS FOR DETERM. ALKALINE PHOSPHATAS (May 28, 1980)
  • K800687 — REAGENT FOR DETERM. GLUCOSE IN H/SERUM (May 28, 1980)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
  • K800676 — REAGENTS FOR DETERM. SODIUM IN HUMAN SUM (May 28, 1980)
  • K800692 — REAGENT FOR DETERM. POTASSIUM/IN HUMAN (May 28, 1980)

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