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510(k) K833777

ANGIOTENSIN CONVERTING ENZYME by Immuno-Diagnostic Laboratories — Product Code CIB

K833777 is an FDA 510(k) premarket notification submitted by Immuno-Diagnostic Laboratories for the device "ANGIOTENSIN CONVERTING ENZYME". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. Immuno-Diagnostic Laboratories has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
October 27, 1983
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 Immuno-Diagnostic Laboratories

  • K811394 — CEA DESALTING DOLUMN SEPHADEX R (June 12, 1981)

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