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510(k) K892654

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST by Princeton Biomedix — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Princeton Biomedix

  • K942052 — LIFESIGN MI MYOGLOBIN (February 7, 1995)
  • K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (July 12, 1994)
  • K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (March 4, 1993)
  • 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)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)
  • K760346 — ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (October 27, 1976)

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