The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Pediatric Control Levels I And Ii.
| Device ID | K872227 |
| 510k Number | K872227 |
| Device Name: | LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-09 |
| Decision Date | 1987-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001997 | K872227 | 000 |
| 00847661000037 | K872227 | 000 |
| 00847661000020 | K872227 | 000 |