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510(k) K040923

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA by Ibl GmbH — Product Code JLS

K040923 is an FDA 510(k) premarket notification submitted by Ibl GmbH for the device "LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA". The FDA issued a decision of Substantially Equivalent on July 22, 2004. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Ibl GmbH has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2004
Date Received
April 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

Other clearances by Ibl GmbH

  • K051969 — TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL (October 3, 2005)
  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 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 JLS

  • K973898 — PROGESTERONE ELISA (November 13, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)
  • K964841 — ELECSYS PROGESTERONE ASSAY (March 24, 1997)
  • K965084 — VIDAS PROESTERONE (PRG) (30 409) (January 9, 1997)
  • K955025 — AXSYM PROGESTERONE (March 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (February 5, 1996)
  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)

FDA data resources