FDA.reportPublic FDA data

Device Listing 1875083841

Listing Summary#

Listing key
1875083841
Premarket submission
K990796
Device
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
Applicant
Cogent Diagnotics , Ltd.
Product code
MOB
Decision date
1999-04-28