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510(k) K930185

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP by Princeton Biomedix — Product Code CEP

K930185 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP". The FDA issued a decision of Substantially Equivalent on March 4, 1993. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Princeton Biomedix has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1993
Date Received
January 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
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)
  • 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)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • 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)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (January 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (November 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (February 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (December 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (August 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)

FDA data resources