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510(k) K972231

OSOM MONO TEST 143 by Wyntek Diagnostics, Inc. — Product Code KTN

K972231 is an FDA 510(k) premarket notification submitted by Wyntek Diagnostics, Inc. for the device "OSOM MONO TEST 143". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Wyntek Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
June 16, 1997
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 Wyntek Diagnostics, Inc.

  • K992658 — OSOM ULTRA STREP A TEST, MODEL 147 (January 18, 2000)
  • K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102 (March 9, 1999)
  • K990576 — OSOM CARD PREGNANCY TEST, MODEL 103 (March 9, 1999)
  • K974159 — OSOM HCG-URINE TEST MODEL 101 (December 24, 1997)
  • K973879 — OSOM CARD HCG-URINE TEST (November 4, 1997)
  • K965227 — OSOM CLASSIC HCG-URINE TEST (115) (February 4, 1997)
  • K965184 — PERFECTA PREGNANCY TEST (February 4, 1997)
  • K961423 — OSOM STREP A TEST (October 11, 1996)
  • K955141 — OSOM HCG COMBO TEST (December 6, 1995)
  • K954178 — OSOM PREGNANCY TEST (October 23, 1995)

Other clearances for product code KTN

  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
  • K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (February 28, 2005)
  • 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)
  • 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)
  • K961550 — QUALITROL MONO CONTROL SERUM SET (September 24, 1996)

FDA data resources