The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Serum Tox Calibrator.
| Device ID | K961372 |
| 510k Number | K961372 |
| Device Name: | SERUM TOX CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011314 | K961372 | 000 |
| 00884883001107 | K961372 | 000 |
| 00884883001114 | K961372 | 000 |
| 00884883001121 | K961372 | 000 |
| 00884883001138 | K961372 | 000 |
| 00630414551043 | K961372 | 000 |
| 00630414551050 | K961372 | 000 |
| 00630414551067 | K961372 | 000 |
| 00630414551074 | K961372 | 000 |
| 00630414551081 | K961372 | 000 |
| 00380740011284 | K961372 | 000 |
| 00380740011291 | K961372 | 000 |
| 00380740011307 | K961372 | 000 |
| 00884883001091 | K961372 | 000 |