The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak.
| Device ID | K052053 |
| 510k Number | K052053 |
| Device Name: | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne S Parsons |
| Correspondent | Suzanne S Parsons BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002048 | K052053 | 000 |
| 00847661001621 | K052053 | 000 |
| 00847661001614 | K052053 | 000 |