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510(k) K900621

FIAGEN(TM) HLH.S by Cyberfluor, Inc. — Product Code CEP

K900621 is an FDA 510(k) premarket notification submitted by Cyberfluor, Inc. for the device "FIAGEN(TM) HLH.S". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Cyberfluor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
February 8, 1990
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 Cyberfluor, Inc.

  • K923410 — FIAGEN PROGESTERONE (December 3, 1992)
  • K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY (January 23, 1991)
  • K904539 — FLAGEN TM FREE T4 (November 30, 1990)
  • K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402 (November 8, 1989)
  • K895396 — CYBERFLUOR FIAGEN TSH (October 31, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K883182 — FIAGEN RUBELLA IGG (October 31, 1988)
  • K882823 — FIAGEN HGH FLUOROIMMUNOASSAY KIT (August 30, 1988)

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