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510(k) K894486

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) by Biokit USA, Inc. — Product Code GTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
July 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Biokit USA, Inc.

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  • 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)
  • K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (November 8, 1989)

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