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510(k) K963408

VISUALINE D HCG by Sun Biomedical Laboratories, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
August 29, 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 Sun Biomedical Laboratories, Inc.

  • K023856 — VISUALINE METHADONE DIPSTRIPTEST (August 25, 2003)
  • K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAIN (May 6, 2003)
  • K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES (April 25, 2002)
  • K020136 — VISUALINE BARBITURATES DIPSTRIP TEST (March 20, 2002)
  • K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY (July 17, 2001)
  • K010177 — VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY (May 17, 2001)
  • K993485 — VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAI (December 27, 1999)
  • K983790 — VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE (March 1, 1999)
  • K981314 — VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE (September 4, 1998)
  • K972032 — VISUALINE II METHAMPHETIMINE (August 12, 1997)

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  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (February 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H (May 30, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)