The following data is part of a premarket notification filed by Medastat Scientific Corp. with the FDA for Paraprep.
| Device ID | K931849 |
| 510k Number | K931849 |
| Device Name: | PARAPREP |
| Classification | Device, Parasite Concentration |
| Applicant | MEDASTAT SCIENTIFIC CORP. 821 MAIN ST. Pittsburgh, PA 15215 |
| Contact | Carmen V D'ambrosio |
| Correspondent | Carmen V D'ambrosio MEDASTAT SCIENTIFIC CORP. 821 MAIN ST. Pittsburgh, PA 15215 |
| Product Code | LKS |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1993-12-02 |