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510(k) K864156

PROGESTERONE SYSTEM BY EIA by Intl. Bioclinical, Inc. — Product Code JLS

K864156 is an FDA 510(k) premarket notification submitted by Intl. Bioclinical, Inc. for the device "PROGESTERONE SYSTEM BY EIA". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Intl. Bioclinical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 23, 1986
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 Intl. Bioclinical, Inc.

  • K913187 — INNOFLUOR(TM) DIGITOXIN REAGENT SET (September 23, 1991)
  • K913186 — INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (August 30, 1991)
  • K911688 — INNOFLUOR(TM) VALPROIC ACID REAGENT SET (July 5, 1991)
  • K911466 — INNOFLUOR VALPROIC ACID CALIBRATOR SET (May 23, 1991)
  • K883533 — ABC FP ANALYZER (December 15, 1988)

Other clearances for product code JLS

  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • 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)

FDA data resources