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510(k) K841862

IMMU-TEC by Medilab Corp. — Product Code DCK

K841862 is an FDA 510(k) premarket notification submitted by Medilab Corp. for the device "IMMU-TEC". The FDA issued a decision of Substantially Equivalent on June 13, 1984. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Medilab Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1984
Date Received
May 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Medilab Corp.

  • K841863 — MONO-TEC (June 13, 1984)
  • K840291 — MCS ALBUMIN REAGENT (March 30, 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)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)

FDA data resources