AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA


codes

Device Classification Name

test system, antineutrophil cytoplasmic antibodies (anca)

510(k) Number K002215
Device Name AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
Original Applicant
COGENT DIAGNOTICS LTD.
bush loan
penicuik
midlothian eh26 0pl, 

GB

eh26 opl

Original Contact danielle m knight
Regulation Number 866.5660
Classification Product Code
MOB  
Date Received 07/24/2000
Decision Date 09/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No