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510(k) K813484

PROGESTERONE KIT BY RIA by Immuchem Corp. — Product Code JLS

K813484 is an FDA 510(k) premarket notification submitted by Immuchem Corp. for the device "PROGESTERONE KIT BY RIA". The FDA issued a decision of Substantially Equivalent on December 22, 1981. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Immuchem Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1981
Date Received
December 1, 1981
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 Immuchem Corp.

  • K883726 — THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (December 15, 1988)
  • K871317 — FOLLICLE STIMULATING HORMONE (HFSH) (May 20, 1987)
  • K871542 — HPROLACTIN KIT (May 14, 1987)
  • K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (March 13, 1987)
  • K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT (November 24, 1986)
  • K860559 — ANDROSTENEDIONE 125I KIT BY RIA (March 14, 1986)
  • K854094 — IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (February 28, 1986)
  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K822509 — COVALENT COAT RIA KIT (September 28, 1982)
  • K822140 — IMMUCHEM COVALENT-COAT (August 5, 1982)

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