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510(k) K955141

OSOM HCG COMBO TEST by Wyntek Diagnostics, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K965227 — OSOM CLASSIC HCG-URINE TEST (115) (February 4, 1997)
  • K961423 — OSOM STREP A TEST (October 11, 1996)
  • K954178 — OSOM PREGNANCY TEST (October 23, 1995)

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