The following data is part of a premarket notification filed by Hangzhou Alltest Biotech Co., Ltd with the FDA for Single And Multi-drug Rapid Test Panel With Adulteration (urine), Single And Multi-drug Rapid Test Panel (urine), Single And Multi-drug Rapid Test Cup With Adulteration (urine), Single And Multi-drug Rapid Test Cup (urine), Single Drug Rapid Test Dip.
| Device ID | K182738 |
| 510k Number | K182738 |
| Device Name: | Single And Multi-Drug Rapid Test Panel With Adulteration (Urine), Single And Multi-Drug Rapid Test Panel (Urine), Single And Multi-Drug Rapid Test Cup With Adulteration (Urine), Single And Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dip |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Hangzhou AllTest Biotech Co., Ltd #550, Yinhai Street Hangzhou Economic & Technological Development Area Hangzhou, CN 310018 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675 |
| 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 | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGI |
| Subsequent Product Code | NGL |
| Subsequent Product Code | NGM |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066005019 | K182738 | 000 |
| 06936983144667 | K182738 | 000 |
| 06936983144674 | K182738 | 000 |
| 10722066006754 | K182738 | 000 |
| 10722066006747 | K182738 | 000 |
| 00722066005507 | K182738 | 000 |
| 00722066005514 | K182738 | 000 |
| 00722066004784 | K182738 | 000 |
| 00722066004876 | K182738 | 000 |
| 00722066004883 | K182738 | 000 |
| 00722066004890 | K182738 | 000 |
| 00722066004906 | K182738 | 000 |
| 16936983150634 | K182738 | 000 |