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510(k) K782009

RIA KIT, PROGESTERONE by The Upjohn Co. — Product Code JLS

K782009 is an FDA 510(k) premarket notification submitted by The Upjohn Co. for the device "RIA KIT, PROGESTERONE". The FDA issued a decision of Substantially Equivalent on March 2, 1979. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. The Upjohn Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
December 1, 1978
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 The Upjohn Co.

  • K902004 — TROBICIN SUSCEPTIBILITY POWDER (May 15, 1990)
  • K900455 — ZEFAZONE SUSCEPTIBILITY POWDER (February 9, 1990)
  • K810853 — CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT (May 29, 1981)
  • K780792 — TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (June 13, 1978)
  • K760920 — CAT-A-KIT (November 9, 1976)

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