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510(k) K965184

PERFECTA PREGNANCY TEST by Wyntek Diagnostics, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1997
Date Received
December 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
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)
  • K965227 — OSOM CLASSIC HCG-URINE TEST (115) (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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