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510(k) K850590

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN by Applications Lab — Product Code DCK

K850590 is an FDA 510(k) premarket notification submitted by Applications Lab for the device "SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN". The FDA issued a decision of Substantially Equivalent on March 1, 1985. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Applications Lab has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
February 13, 1985
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 Applications Lab

  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (March 14, 1985)
  • K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN (March 5, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C3 (March 5, 1985)
  • K850584 — SPQ TEST SYSTEM FOR HAPTOGLOBIN (March 5, 1985)
  • K850583 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (March 1, 1985)
  • K850585 — SPQ TEST SYSTEM FOR COMPLEMENT C4 (March 1, 1985)
  • K850582 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (March 1, 1985)

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