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510(k) K983113

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT by Syntron Bioresearch, Inc. — Product Code CEP

K983113 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
September 4, 1998
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 Syntron Bioresearch, Inc.

  • K993491 — QUICKPAC II ONE STEP OPIATES TEST (October 29, 1999)
  • K993490 — QUICKSTRIP ONE STEP OPIATES TEST (October 29, 1999)
  • K992990 — QUICKPAC II ONE STEP COCAINE TEST (September 20, 1999)
  • K992748 — DRUGCHECK X MULTIDRUG SCREENING DEVICE (September 2, 1999)
  • K992207 — QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM (July 22, 1999)
  • K990325 — QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE (June 24, 1999)
  • K981292 — QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST (May 26, 1998)
  • K981019 — QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (May 7, 1998)
  • K980349 — QUICKPAC II ONE STEP BARBITURATE TEST (March 3, 1998)
  • K974712 — QUIKSTRIP ONE STEP BARBITURATE TEST (February 12, 1998)

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