The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Multi-panel Drug Screen Dip Card/cup Tests, Chemtrue Multi-panel Drug Screen Dip Card/cup With Opi 2000 Tests.
| Device ID | K153192 |
| 510k Number | K153192 |
| Device Name: | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup With OPI 2000 Tests |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Chemtron Biotech, Inc. 9245 Brown Deer Road San Diego, CA 92121 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang Chemtron Biotech, Inc. 9245 Brown Deer Road San Diego, CA 92121 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812203030520 | K153192 | 000 |
| 00812203030599 | K153192 | 000 |
| 00812203030605 | K153192 | 000 |
| 00812203030582 | K153192 | 000 |
| 00812203030575 | K153192 | 000 |
| 00812203030568 | K153192 | 000 |
| 00812203030551 | K153192 | 000 |
| 00812203030223 | K153192 | 000 |
| 00812203030353 | K153192 | 000 |
| 00812203030360 | K153192 | 000 |
| 00812203030377 | K153192 | 000 |
| 00812203030483 | K153192 | 000 |
| 00812203030490 | K153192 | 000 |
| 00812203030506 | K153192 | 000 |
| 00812203030513 | K153192 | 000 |
| 00812203030698 | K153192 | 000 |