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510(k) K973692

UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE by United Biotech, Inc. — Product Code DCK

K973692 is an FDA 510(k) premarket notification submitted by United Biotech, Inc. for the device "UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE". The FDA issued a decision of Substantially Equivalent on February 9, 1998. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. United Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1998
Date Received
September 26, 1997
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 United Biotech, Inc.

  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K973154 — UBI MAGIWEL MARIJUANA METABOLITES (July 22, 1998)
  • K973153 — UBI MAGIWEL AMPHETAMINE METABOLITES (October 28, 1997)
  • K973156 — UBI MAGIWEL COCAINE METABOLITES (October 28, 1997)
  • K973155 — UBI MAGIWEL OPIATE METABOLITES (October 28, 1997)
  • K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (July 8, 1996)
  • K961236 — UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (May 30, 1996)
  • K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE (July 5, 1995)
  • K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (August 10, 1993)
  • K905473 — UBI MAGIWEL CORTISOL QUANTITATIVE (January 31, 1991)

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