The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Drugs Of Abuse Urine Calibrators And Controls.
| Device ID | K983159 |
| 510k Number | K983159 |
| Device Name: | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS |
| 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 | 1998-09-09 |
| Decision Date | 1998-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005801 | K983159 | 000 |
| 00884883005143 | K983159 | 000 |
| 00884883005211 | K983159 | 000 |
| 00884883005228 | K983159 | 000 |
| 00884883005235 | K983159 | 000 |
| 00884883011458 | K983159 | 000 |
| 00884883011502 | K983159 | 000 |
| 00884883011571 | K983159 | 000 |
| 00630414505718 | K983159 | 000 |
| 00380740005764 | K983159 | 000 |
| 00380740005771 | K983159 | 000 |
| 00380740005788 | K983159 | 000 |
| 00380740005795 | K983159 | 000 |
| 00884883002647 | K983159 | 000 |