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510(k) K955141

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

K955141 is an FDA 510(k) premarket notification submitted by Wyntek Diagnostics, Inc. for the device "OSOM HCG COMBO TEST". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Wyntek Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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)
  • 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)
  • K972231 — OSOM MONO TEST 143 (August 26, 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)
  • K954178 — OSOM PREGNANCY TEST (October 23, 1995)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources