The following data is part of a premarket notification filed by Akers Laboratories, Inc. with the FDA for Healthtest Heparin/platelet Factor 4 Antibody Assay.
| Device ID | K040293 |
| 510k Number | K040293 |
| Device Name: | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | AKERS LABORATORIES, INC. 201 GROVE RD. Thorofare, NJ 08086 |
| Contact | Barbara A Bagby |
| Correspondent | Barbara A Bagby AKERS LABORATORIES, INC. 201 GROVE RD. Thorofare, NJ 08086 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-05-28 |
| Summary: | summary |