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510(k) K864174

UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE by United Biotech, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
October 24, 1986
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 United Biotech, Inc.

  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K973154 — UBI MAGIWEL MARIJUANA METABOLITES (July 22, 1998)
  • K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (February 9, 1998)
  • K973153 — UBI MAGIWEL AMPHETAMINE METABOLITES (October 28, 1997)
  • K973155 — UBI MAGIWEL OPIATE METABOLITES (October 28, 1997)
  • K973156 — UBI MAGIWEL COCAINE METABOLITES (October 28, 1997)
  • K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (July 8, 1996)
  • K961236 — UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (May 30, 1996)
  • K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE (July 5, 1995)
  • K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (August 10, 1993)

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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)
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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)