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510(k) K800774

RENCTK by Sorin Biomedica, Fiat, USA, Inc. — Product Code CIB

K800774 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "RENCTK". The FDA issued a decision of Substantially Equivalent on April 21, 1980. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. 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, Angiotensin I And Renin
Device Class
Class II
Regulation Number
862.1085
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 CIB

  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)
  • K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (January 1, 2013)
  • K062120 — CISBIO RENIN RIA TEST (March 30, 2007)
  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AN (September 6, 2001)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)
  • K954299 — BUHLMANN ANGIOSTENSIN II RIA (October 19, 1995)
  • K940004 — AI-PHOTODIAGNOSTIC (August 4, 1995)
  • K925998 — ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (January 6, 1993)
  • K850054 — RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (March 29, 1985)

FDA data resources