PLASTINEX
Test, Time, Prothrombin
BIO/DATA CORP.
The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Plastinex.
Pre-market Notification Details
| Device ID | K852484 |
| 510k Number | K852484 |
| Device Name: | PLASTINEX |
| Classification | Test, Time, Prothrombin |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | James W Eichelberge |
| Correspondent | James W Eichelberge BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-11 |
| Decision Date | 1985-08-12 |
Trademark Results [PLASTINEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASTINEX 73565692 1396300 Live/Registered |
BIO/DATA CORPORATION 1985-10-28 |
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