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510(k) K832297

HYDROXYPROGESTERONE-17 by Diagnostics Biochem Canada, Inc. — Product Code JLS

K832297 is an FDA 510(k) premarket notification submitted by Diagnostics Biochem Canada, Inc. for the device "HYDROXYPROGESTERONE-17". The FDA issued a decision of Substantially Equivalent on September 1, 1983. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Diagnostics Biochem Canada, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
July 13, 1983
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 Diagnostics Biochem Canada, Inc.

  • K030730 — FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (August 18, 2003)
  • K014120 — TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (February 8, 2002)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)
  • K781310 — HUMAN CHORIONIC GONADO.-BETA RIA KIT (August 31, 1978)

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