The following data is part of a premarket notification filed by First Check Diagnostics Llc with the FDA for First Check Multi Drug Cup 12 For Marijuana (thc), Cocaine (coc), Amphetamine (amp), Methamphetamine (met), Ecstasy.
| Device ID | K052115 |
| 510k Number | K052115 |
| Device Name: | FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | FIRST CHECK DIAGNOSTICS LLC 13 SPECTRUM POINTE DR. Lake Forest, CA 92630 |
| Contact | Kevin J Gadawski |
| Correspondent | Kevin J Gadawski FIRST CHECK DIAGNOSTICS LLC 13 SPECTRUM POINTE DR. Lake Forest, CA 92630 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-04 |
| Decision Date | 2005-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817405020348 | K052115 | 000 |
| 00858998006524 | K052115 | 000 |
| 00858998006517 | K052115 | 000 |
| 00858998006500 | K052115 | 000 |
| 00858886006315 | K052115 | 000 |
| 00858886006308 | K052115 | 000 |
| 00858886006292 | K052115 | 000 |
| 00643281801128 | K052115 | 000 |
| 00817405020621 | K052115 | 000 |
| 00817405020614 | K052115 | 000 |
| 00817405020591 | K052115 | 000 |
| 00817405020584 | K052115 | 000 |
| 00643281069047 | K052115 | 000 |
| 00643281067555 | K052115 | 000 |
| 00858998006531 | K052115 | 000 |
| 00858998006579 | K052115 | 000 |
| 00858998006593 | K052115 | 000 |
| 00817405020331 | K052115 | 000 |
| 00817405020324 | K052115 | 000 |
| 00817405020263 | K052115 | 000 |
| 00817405020256 | K052115 | 000 |
| 00817405020249 | K052115 | 000 |
| 00817405020232 | K052115 | 000 |
| 00817405020225 | K052115 | 000 |
| 00816610020662 | K052115 | 000 |
| 00816610020655 | K052115 | 000 |
| 00816565020243 | K052115 | 000 |
| 00816565020205 | K052115 | 000 |
| 00858998006685 | K052115 | 000 |
| 00858998006609 | K052115 | 000 |
| 00643281061553 | K052115 | 000 |