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510(k) K981183

CARESIDE GLUCOSE by Exigent Diagnostics, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
April 1, 1998
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 Exigent Diagnostics, Inc.

  • K982118 — CARESIDE ANALYZER (July 24, 1998)
  • K981899 — CARESIDE HDL-CHOLESTEROL (July 14, 1998)
  • K980043 — CARESIDE CREATININE (March 30, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K980057 — CARESIDE BUN (February 5, 1998)
  • K980041 — CARESIDE ALBUMIN (February 4, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K980055 — CARESIDE GLOBULIN (January 28, 1998)

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