The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Abuscreen Online For Methaqualone.
| Device ID | K945187 |
| 510k Number | K945187 |
| Device Name: | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE |
| Classification | Radioimmunoassay, Methaqualone |
| 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 | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336166109 | K945187 | 000 |