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510(k) K895094

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT by Hybritech, Inc. — Product Code CEP

K895094 is an FDA 510(k) premarket notification submitted by Hybritech, Inc. for the device "TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Hybritech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
August 14, 1989
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 Hybritech, Inc.

  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)
  • K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (January 11, 1994)
  • K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET (February 17, 1993)
  • K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (July 30, 1992)
  • K920556 — TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (July 17, 1992)
  • K921252 — TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (July 17, 1992)
  • K921763 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (June 9, 1992)
  • K912439 — TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (August 28, 1991)
  • K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY (July 24, 1991)

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