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510(k) K874678

I.M.N. LATEX by Biokit USA, Inc. — Product Code KTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1987
Date Received
November 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
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)

Other clearances for product code KTN

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  • K030215 — BIORAPID MONONUCLEOSIS (February 24, 2003)
  • K012901 — COLOR-MONOGEN (September 27, 2001)
  • K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (January 28, 1999)
  • K981946 — CLEARVIEW IM (December 10, 1998)
  • K972457 — MONOCOL/LEX-IM TEST (December 1, 1997)
  • K972231 — OSOM MONO TEST 143 (August 26, 1997)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (February 4, 1997)