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510(k) K840290

MCS TOTAL PROTEIN REAGENT by Medilab Corp. — Product Code CEK

K840290 is an FDA 510(k) premarket notification submitted by Medilab Corp. for the device "MCS TOTAL PROTEIN REAGENT". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Medilab Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
January 24, 1984
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 Medilab Corp.

  • K841862 — IMMU-TEC (June 13, 1984)
  • K841863 — MONO-TEC (June 13, 1984)
  • K840291 — MCS ALBUMIN REAGENT (March 30, 1984)
  • K840289 — LYSE-TEC (March 5, 1984)
  • K832918 — PREGNA-TEC (November 3, 1983)
  • K832527 — PREGNA-TEC (September 12, 1983)

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)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 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)

FDA data resources