The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online Negative Cal/control Cal Pack And Mil Calibration Pack.
| Device ID | K935550 |
| 510k Number | K935550 |
| Device Name: | ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK |
| Classification | Calibrators, Drug Mixture |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-01-03 |