Home / 510(k) Clearances / K980041

510(k) K980041

CARESIDE ALBUMIN by Exigent Diagnostics, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1998
Date Received
January 6, 1998
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 Exigent Diagnostics, Inc.

  • K982118 — CARESIDE ANALYZER (July 24, 1998)
  • K981899 — CARESIDE HDL-CHOLESTEROL (July 14, 1998)
  • K981183 — CARESIDE GLUCOSE (May 7, 1998)
  • K980043 — CARESIDE CREATININE (March 30, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K980057 — CARESIDE BUN (February 5, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K980055 — CARESIDE GLOBULIN (January 28, 1998)

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  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI (June 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)