The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek Pediatric Control, Bilevel Minipak.
| Device ID | K130963 |
| 510k Number | K130963 |
| Device Name: | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-08 |
| Decision Date | 2013-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004424 | K130963 | 000 |
| 00847661004417 | K130963 | 000 |
| 00847661004400 | K130963 | 000 |