GAMMA-B 25-HYDROXY VITAMIN D RIA


Device Classification Name

system, test, vitamin d

510(k) Number K991998
Device Name GAMMA-B 25-HYDROXY VITAMIN D RIA
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 didcot way,
bolden business park
boldon, tyne & wear, 

GB

ne35 9pd

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

GB

ne35 9pd

Correspodent Contact paul puntin
Regulation Number 862.1825
Classification Product Code
MRG  
Date Received 06/14/1999
Decision Date 09/17/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No