The following data is part of a premarket notification filed by Columbia Diagnostics, Inc. with the FDA for Accuracy.
Device ID | K854119 |
510k Number | K854119 |
Device Name: | ACCURACY |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | COLUMBIA DIAGNOSTICS, INC. 8001 RESEARCH WAY Springfield, VA 22153 |
Contact | John Innocenti |
Correspondent | John Innocenti COLUMBIA DIAGNOSTICS, INC. 8001 RESEARCH WAY Springfield, VA 22153 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-09 |
Decision Date | 1985-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCURACY 87573846 5602630 Live/Registered |
Q&A7 LLC 2017-08-17 |
ACCURACY 75410861 2282121 Dead/Cancelled |
Milliken & Company 1997-12-24 |
ACCURACY 73448507 1292847 Dead/Cancelled |
Mead Corporation, The 1983-10-17 |
ACCURACY 72179571 0787567 Dead/Expired |
WESTERN TABLET & STATIONERY CORPORATION 1963-10-22 |