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510(k) K943188

SEALITE SCIENCE, INC. AQUALITE(R) LH by Sealite Sciences, Inc. — Product Code CEP

K943188 is an FDA 510(k) premarket notification submitted by Sealite Sciences, Inc. for the device "SEALITE SCIENCE, INC. AQUALITE(R) LH". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Sealite Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
July 5, 1994
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 Sealite Sciences, Inc.

  • K974551 — SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY (December 22, 1997)
  • K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (September 25, 1997)
  • K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (June 24, 1997)
  • K970483 — AQUALITE INTACT PTH (April 14, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (February 14, 1997)
  • K964925 — SEALITE SCIENCES, INC. AQUALITE LH (January 22, 1997)
  • K942661 — AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (January 17, 1995)
  • K943437 — AQUALITE FSH (December 28, 1994)
  • K941983 — SEALITE SCIENCES INC. (August 18, 1994)

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