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510(k) K980042

CARESIDE TOTAL PROTEIN by Exigent Diagnostics, Inc. — Product Code CEK

K980042 is an FDA 510(k) premarket notification submitted by Exigent Diagnostics, Inc. for the device "CARESIDE TOTAL PROTEIN". The FDA issued a decision of Substantially Equivalent on February 4, 1998. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Exigent Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

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
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
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)
  • K980041 — CARESIDE ALBUMIN (February 4, 1998)
  • K980055 — CARESIDE GLOBULIN (January 28, 1998)

Other clearances for product code CEK

  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (March 2, 1998)
  • K971524 — TOTAL PROTEIN OR TP (May 16, 1997)
  • K961864 — CSF/URINE TOTAL PROTEIN (October 24, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K955936 — TOTAL PROTEIN REAGENT (March 12, 1996)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K943004 — TOTAL PROTEIN QVET (December 9, 1994)

FDA data resources