IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL…


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K111938
Device Name IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL…
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 didcot way,
bolden business park
boldon, tyne & wear, 

GB

ne35 9pd

Applicant Contact mick fenton
Correspondent
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 didcot way,
bolden business park
boldon, tyne & wear, 

GB

ne35 9pd

Correspodent Contact mick fenton
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 07/08/2011
Decision Date 02/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No