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510(k) K920920

ELISA TUBE LH TEST KIT by Bio Clinic Co. — Product Code CEP

K920920 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "ELISA TUBE LH TEST KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1992. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1992
Date Received
February 28, 1992
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 Bio Clinic Co.

  • K930791 — AMERICAN POWER CONVERSIONS, BACK-UPS 600 (August 6, 1993)
  • K932480 — PRISM (July 21, 1993)
  • K926189 — ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE (June 24, 1993)
  • K921958 — ELISA TUBE TSH TEST (July 2, 1992)
  • K922140 — ORTHODERM CONVERTIBLE II (May 27, 1992)
  • K921212 — MIRCO ELISA HPL TEST KIT (May 7, 1992)
  • K921211 — NOW PREGNANCY TEST KIT (May 7, 1992)
  • K920921 — ELISA TUBE PROLACTIN TEST KIT (April 8, 1992)
  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)
  • K920917 — ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (March 26, 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)
  • 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