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510(k) K954299

BUHLMANN ANGIOSTENSIN II RIA by Buhlmann Laboratories AG — Product Code CIB

K954299 is an FDA 510(k) premarket notification submitted by Buhlmann Laboratories AG for the device "BUHLMANN ANGIOSTENSIN II RIA". The FDA issued a decision of Substantially Equivalent on October 19, 1995. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. Buhlmann Laboratories AG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
September 14, 1995
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 Buhlmann Laboratories AG

  • K191718 — Buhlmann fCAL turbo and CALEX Cap (September 24, 2019)
  • K190784 — BUHLMANN fCAL turbo (June 25, 2019)
  • K181012 — BUHLMANN fCAL ELISA (June 4, 2018)

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)
  • K940004 — AI-PHOTODIAGNOSTIC (August 4, 1995)
  • K925998 — ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (January 6, 1993)
  • K850054 — RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (March 29, 1985)
  • K842966 — RENIN RADIOIMMUNOASSAY TEST KIT (October 11, 1984)

FDA data resources