IDS-ISYS INTACT PTH


Device Classification Name

radioimmunoassay, parathyroid hormone

510(k) Number K103325
Device Name IDS-ISYS INTACT PTH
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 862.1545
Classification Product Code
CEW  
Subsequent Product Codes
JIT   JJX  
Date Received 11/12/2010
Decision Date 02/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No