The following data is part of a premarket notification filed by Hyphen Biomed with the FDA for Zymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040a.
| Device ID | K071255 |
| 510k Number | K071255 |
| Device Name: | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | HYPHEN BIOMED 6560 GOVE COURT Mason, OH 45040 |
| Contact | Ola Anderson |
| Correspondent | Ola Anderson HYPHEN BIOMED 6560 GOVE COURT Mason, OH 45040 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2007-09-07 |
| Summary: | summary |