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510(k) K894705

BIOSPOT HCG-RAPID PREGNANCY TEST by Princeton Biomedix — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1989
Date Received
July 25, 1989
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

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  • K925183 — BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (February 23, 1993)
  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)
  • K760346 — ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (October 27, 1976)

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  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)