The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-cardiolipin Igg Elisa.
Device ID | K992440 |
510k Number | K992440 |
Device Name: | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA |
Classification | System, Test, Anticardiolipin Immunological |
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 | MID |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-22 |
Decision Date | 1999-09-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816879020151 | K992440 | 000 |