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510(k) K964694

ELECSYS LH ASSAY by Boehringer Mannheim Corp. — Product Code CEP

K964694 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECSYS LH ASSAY". The FDA issued a decision of Substantially Equivalent on Jan 24, 1997. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 24, 1997
Date Received
Nov 22, 1996
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 Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (Feb 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (Feb 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (Feb 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (Jan 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (Dec 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (Dec 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (Dec 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (Nov 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (Nov 12, 1998)
  • K982949 — ELECSYS PSA, MODEL 2010 (Oct 27, 1998)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (Jan 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (Nov 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (Feb 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (Dec 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (Aug 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (Oct 12, 2000)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)

FDA data resources