Home / 510(k) Clearances / K800775

510(k) K800775

ALDOCTK-125 by Sorin Biomedica, Fiat, USA, Inc. — Product Code CJM

K800775 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "ALDOCTK-125". The FDA issued a decision of Substantially Equivalent on April 21, 1980. The device falls under product code CJM (Radioimmunoassay, Aldosterone), a Class II device regulated under 21 CFR 862.1045. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1980
Date Received
April 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Aldosterone
Device Class
Class II
Regulation Number
862.1045
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)
  • K925615 — SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (March 26, 1993)
  • K925369 — BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS (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 CJM

  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K130321 — LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBR (April 9, 2013)
  • K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (June 1, 2005)
  • K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (July 31, 2003)
  • K943397 — DSL ACTIVE ALDOSTERONE RIA (DSL 8600) (February 13, 1995)
  • K921205 — DSL ACTIVE ALDOSTERONE (DSL 8600) (July 10, 1992)
  • K862204 — RSL (125I) ALDOSTERONE KIT (September 25, 1986)
  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K831178 — COAT-A-COUNT NO-EXTRACTION ALDOSTERONE (May 27, 1983)
  • K781504 — 125I-ALDOSTERONE RIA DIAG. KIT (November 22, 1978)

FDA data resources