The following data is part of a premarket notification filed by Akers Biosciences, Inc. with the FDA for Heparin/platelet Factor 4 Antibody Serum Panel.
| Device ID | K052697 |
| 510k Number | K052697 |
| Device Name: | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL |
| Classification | Plasma, Coagulation Control |
| Applicant | Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Contact | Barbara A Bagby |
| Correspondent | Barbara A Bagby Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2006-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00708872000011 | K052697 | 000 |
| 00708872000004 | K052697 | 000 |