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510(k) K041349

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM by Ibl GmbH — Product Code CHP

K041349 is an FDA 510(k) premarket notification submitted by Ibl GmbH for the device "LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM". The FDA issued a decision of Substantially Equivalent on September 24, 2004. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Ibl GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
May 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estradiol
Device Class
Class I
Regulation Number
862.1260
Review Panel
CH
Submission Type

Other clearances by Ibl GmbH

  • K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL (October 3, 2005)
  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIV (February 27, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)

Other clearances for product code CHP

  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)
  • K970386 — ACS ESTADIOL-6 II (June 4, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (February 25, 1997)
  • K965109 — ELECSYS ESTRADIOL ASSAY (February 18, 1997)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (December 13, 1995)
  • K953605 — ULTRA-SENSITIVE ESTRADIOL (October 2, 1995)
  • K951360 — ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (May 2, 1995)

FDA data resources