The following data is part of a premarket notification filed by Columbia Diagnostics, Inc. with the FDA for Quality Control Material (assayed).
| Device ID | K935819 |
| 510k Number | K935819 |
| Device Name: | QUALITY CONTROL MATERIAL (ASSAYED) |
| Classification | Alcohol Control Materials |
| Applicant | COLUMBIA DIAGNOSTICS, INC. 8001 RESEARCH WAY Springfield, VA 22153 |
| Contact | Stanley P Goldenberg |
| Correspondent | Stanley P Goldenberg COLUMBIA DIAGNOSTICS, INC. 8001 RESEARCH WAY Springfield, VA 22153 |
| Product Code | DKC |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1994-03-22 |