The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Cephalinex Activated Ptt Reagent.
| Device ID | K852195 |
| 510k Number | K852195 |
| Device Name: | CEPHALINEX ACTIVATED PTT REAGENT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | James W Elchelberge |
| Correspondent | James W Elchelberge BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-08-12 |