OCTEIA 25-HYDROXY VITAMIN D


Device Classification Name

system, test, vitamin d

510(k) Number K021163
Device Name OCTEIA 25-HYDROXY VITAMIN D
Original Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 didcot way,
bolden business park
boldon, tyne & wear, 

GB

ne35 9pd

Original Contact paul puntin
Regulation Number 862.1825
Classification Product Code
MRG  
Date Received 04/11/2002
Decision Date 05/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls