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510(k) K022829

INSTANT-VIEW LH OVULATION PREDICTING TEST by Alfa Scientific Designs, Inc. — Product Code CEP

K022829 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW LH OVULATION PREDICTING TEST". The FDA issued a decision of Substantially Equivalent on November 5, 2002. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2002
Date Received
August 26, 2002
Clearance Type
Abbreviated
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 Alfa Scientific Designs, Inc.

  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)
  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine (June 24, 2016)
  • K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (October 7, 2013)
  • K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI- (July 6, 2010)
  • K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (June 21, 2007)
  • K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, (May 7, 2007)
  • K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT (July 25, 2006)
  • K042227 — INSTANT-VIEW TROPONIN I TEST (November 19, 2004)
  • K024360 — INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (June 10, 2003)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (January 16, 2003)
  • 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)
  • K990249 — OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MOD (March 22, 1999)

FDA data resources