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510(k) K800678

REAGENTS FOR DETERM. ALBUMIN IN HUMAN by Diagnostic Solutions, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

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  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800689 — REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (May 30, 1980)
  • K800690 — REAGENT FOR DETERM. INORGANIC/PHOSPHORUS (May 28, 1980)
  • K800680 — REAGENTS FOR DETERM. CALCIUM IN HUMAN (May 28, 1980)
  • K800685 — REAGENT FOR DETERM. CREATININE IN H/SERU (May 28, 1980)
  • K800677 — REAGENTS FOR DETERM. SERUM IRON IN HUMAN (May 28, 1980)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)

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