The following data is part of a premarket notification filed by Precision Technology, Inc. with the FDA for Sediplast.
Device ID | K840500 |
510k Number | K840500 |
Device Name: | SEDIPLAST |
Classification | Test, Erythrocyte Sedimentation Rate |
Applicant | PRECISION TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JPH |
CFR Regulation Number | 864.6700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-06 |
Decision Date | 1984-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SEDIPLAST 79101514 4120228 Live/Registered |
LP ITALIANA S.P.A. 2011-06-29 |