The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Kinetic Fibrinogen Assay.
| Device ID | K881150 |
| 510k Number | K881150 |
| Device Name: | KINETIC FIBRINOGEN ASSAY |
| Classification | Test, Fibrinogen |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | W Eichelberger |
| Correspondent | W Eichelberger BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-17 |
| Decision Date | 1988-03-28 |