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510(k) K800681

REAGENTS FOR DETERM. CO2 IN HUMAN SERUM by Diagnostic Solutions, Inc. — Product Code KMS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenolphthalein Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

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  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • 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)

Other clearances for product code KMS

  • K872886 — CARBON DIOXIDE (August 13, 1987)
  • K870025 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (March 13, 1987)
  • K802162 — CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (October 10, 1980)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)