The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Microsample Coagulation Analyser, Model 110wp.
| Device ID | K860342 |
| 510k Number | K860342 |
| Device Name: | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | James Eichelberger |
| Correspondent | James Eichelberger BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-03-04 |