The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Anti-beta2 Glycoprotein I (b2gp1) Igg Elisa.
| Device ID | K030701 |
| 510k Number | K030701 |
| Device Name: | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin J Lawson |
| Correspondent | Kevin J Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-06 |
| Decision Date | 2003-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714004353 | K030701 | 000 |
| 00845714002793 | K030701 | 000 |