The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-gbm Elisa, Hy.tec Anti-gmb Elisa.
Device ID | K991890 |
510k Number | K991890 |
Device Name: | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA |
Classification | Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) |
Applicant | COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
Contact | Danielle M Knight |
Correspondent | Danielle M Knight COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland, GB Eh26 Opl |
Product Code | MVJ |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-03 |
Decision Date | 1999-08-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816879020137 | K991890 | 000 |