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510(k) K800774

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

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

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  • 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

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  • 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)