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510(k) K931228

PROGESTERONE RADIOIMMUNOASSAY KIT by Immunotech Corp. — Product Code JLS

K931228 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "PROGESTERONE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 22, 1993. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Immunotech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1993
Date Received
March 10, 1993
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 Immunotech Corp.

  • K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (November 3, 1995)
  • K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (October 20, 1995)
  • K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (September 8, 1995)
  • K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (August 14, 1995)
  • K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (July 5, 1995)
  • K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (May 5, 1995)
  • K934012 — FT4 RADIOIMMUNOASSAY (November 16, 1993)
  • K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (June 24, 1991)
  • K911153 — MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (June 18, 1991)
  • K910411 — MICROZYME TSH ENZYME IMMUNOASSAY KIT (April 3, 1991)

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