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 |