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510(k) K832694

DIRIA-PROGK IMMUNOASSAY by Sorin Biomedica, Fiat, USA, Inc. — Product Code JLS

K832694 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "DIRIA-PROGK IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 11, 1984. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
August 10, 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 Sorin Biomedica, Fiat, USA, Inc.

  • K931444 — PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS (May 27, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925369 — BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS (March 26, 1993)
  • K925615 — SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (March 26, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K925541 — STOCKERT 1/4 BUBBLE SENSOR (February 2, 1993)
  • K922933 — SORIN MONOLYRH INTEGRATED MEMBRANE LUNG (November 30, 1992)
  • K854963 — S80 IMPLANTABLE CARDIAC PACING LEAD (June 24, 1986)
  • K852641 — ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER (January 14, 1986)
  • K851365 — SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM (December 3, 1985)

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