The following data is part of a premarket notification filed by Hycor Biomedical Ltd. with the FDA for Autostat Ii Anti-tissue Transglutaminase Igg Elisa.
| Device ID | K043433 |
| 510k Number | K043433 |
| Device Name: | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| 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 | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020267 | K043433 | 000 |