The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Autostat Ii Anti-b-2 Glycoprotein-i Igm Elisa.
| Device ID | K022944 |
| 510k Number | K022944 |
| Device Name: | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Randy Wilson |
| Correspondent | Randy Wilson HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-05 |
| Decision Date | 2002-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020236 | K022944 | 000 |