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510(k) K840291

MCS ALBUMIN REAGENT by Medilab Corp. — Product Code CIX

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

Other clearances by Medilab Corp.

  • K841863 — MONO-TEC (June 13, 1984)
  • K841862 — IMMU-TEC (June 13, 1984)
  • K840290 — MCS TOTAL PROTEIN REAGENT (March 30, 1984)
  • K840289 — LYSE-TEC (March 5, 1984)
  • K832918 — PREGNA-TEC (November 3, 1983)
  • K832527 — PREGNA-TEC (September 12, 1983)

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