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510(k) K896272

QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL by Biokit USA, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
October 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Biokit USA, Inc.

  • K913467 — TOXOGEN (January 11, 1993)
  • K910541 — BIOKIT RPR (October 18, 1991)
  • K904310 — RHEUMAGEN RF T-CONTROL (May 31, 1991)
  • K910539 — RHEUMAJET RF (April 5, 1991)
  • K910686 — RHEUMAJET CRP (March 19, 1991)
  • K904311 — RHEUMAGEN ASO T-CONTROL (January 25, 1991)
  • K904312 — RHEUMAGEN CRP T-CONTROL (October 1, 1990)
  • K896433 — MODIFIED RUBAGEN (November 29, 1989)
  • K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (November 8, 1989)
  • K894486 — QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) (October 24, 1989)

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