The following data is part of a premarket notification filed by Hycor Biomedical Ltd. with the FDA for Autostat Ii Anti-b-2 Glycoprotein I Iga Elisa.
Device ID | K030397 |
510k Number | K030397 |
Device Name: | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA |
Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
Applicant | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh, GB Eh26 Opl |
Contact | Danielle M Knight |
Correspondent | Danielle M Knight HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh, GB Eh26 Opl |
Product Code | MSV |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-06 |
Decision Date | 2003-03-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816879020243 | K030397 | 000 |