The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Homecheck Multiple Drug Cup Test.
| Device ID | K071489 |
| 510k Number | K071489 |
| Device Name: | HOMECHECK MULTIPLE DRUG CUP TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Contact | Armando A Torrescano |
| Correspondent | Armando A Torrescano Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| 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 | LFH |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-30 |
| Decision Date | 2008-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20748349000407 | K071489 | 000 |
| 10748349000103 | K071489 | 000 |
| 20748349000056 | K071489 | 000 |
| 20748349000049 | K071489 | 000 |
| 20748349000018 | K071489 | 000 |
| 10868348000253 | K071489 | 000 |
| 20863480002117 | K071489 | 000 |
| 20863480002100 | K071489 | 000 |
| 00748349000724 | K071489 | 000 |
| 10763924811530 | K071489 | 000 |
| 10763924087539 | K071489 | 000 |
| 10763924086532 | K071489 | 000 |
| 10864040000348 | K071489 | 000 |
| 10864040000331 | K071489 | 000 |
| 10864040000324 | K071489 | 000 |
| 20748349000117 | K071489 | 000 |
| 20748349000131 | K071489 | 000 |
| 00748349000144 | K071489 | 000 |
| 20748349000346 | K071489 | 000 |
| 20748349000339 | K071489 | 000 |
| 20748349000315 | K071489 | 000 |
| 20748349000308 | K071489 | 000 |
| 20748349000292 | K071489 | 000 |
| 20748349000285 | K071489 | 000 |
| 20748349000278 | K071489 | 000 |
| 20748349000247 | K071489 | 000 |
| 20748349000223 | K071489 | 000 |
| 20748349000209 | K071489 | 000 |
| 20748349000193 | K071489 | 000 |
| 20748349000179 | K071489 | 000 |
| 10748349000165 | K071489 | 000 |
| 20748349000155 | K071489 | 000 |
| 10864040000317 | K071489 | 000 |