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510(k) K965227

OSOM CLASSIC HCG-URINE TEST (115) by Wyntek Diagnostics, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1997
Date Received
December 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Wyntek Diagnostics, Inc.

  • K992658 — OSOM ULTRA STREP A TEST, MODEL 147 (January 18, 2000)
  • K990576 — OSOM CARD PREGNANCY TEST, MODEL 103 (March 9, 1999)
  • K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102 (March 9, 1999)
  • K974159 — OSOM HCG-URINE TEST MODEL 101 (December 24, 1997)
  • K973879 — OSOM CARD HCG-URINE TEST (November 4, 1997)
  • K972231 — OSOM MONO TEST 143 (August 26, 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)

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  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
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  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)