The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Bilirubin Standard.
| Device ID | K882059 |
| 510k Number | K882059 |
| Device Name: | BILIRUBIN STANDARD |
| Classification | Calibrator, Secondary |
| Applicant | VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Contact | Anthony J Dimonte |
| Correspondent | Anthony J Dimonte VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1988-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852553007322 | K882059 | 000 |
| 00852553007308 | K882059 | 000 |
| 00852553007117 | K882059 | 000 |
| 00852553007070 | K882059 | 000 |
| 00852553007063 | K882059 | 000 |