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510(k) K010244

SURE CHECK OVULATION PREDICTOR by Chembio Diagnostic Systems, Inc. — Product Code CEP

K010244 is an FDA 510(k) premarket notification submitted by Chembio Diagnostic Systems, Inc. for the device "SURE CHECK OVULATION PREDICTOR". The FDA issued a decision of Substantially Equivalent on May 2, 2001. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Chembio Diagnostic Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2001
Date Received
January 25, 2001
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 Chembio Diagnostic Systems, Inc.

  • K200506 — DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (June 3, 2020)
  • K011550 — HCG STAT PAK ULTRA-FAST (August 14, 2001)
  • K011551 — SURE CHECK PREGNANCY TEST (August 14, 2001)
  • K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY (February 12, 1999)
  • K961965 — SURE CHECK PREGNANCY TEST (June 24, 1996)
  • K923925 — HCG STAT-PAK (December 24, 1992)

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)
  • 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)
  • K990249 — OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MOD (March 22, 1999)

FDA data resources