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510(k) K791051

PROGESTERONE RADIOIMMUNOASSAY KIT by Cis Radiopharmaceuticals, Inc. — Product Code JLS

K791051 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "PROGESTERONE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
June 6, 1979
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 Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 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