The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Ammonia/iron Standard Kit.
| Device ID | K972333 |
| 510k Number | K972333 |
| Device Name: | AMMONIA/IRON STANDARD KIT |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-23 |
| Decision Date | 1997-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852553007377 | K972333 | 000 |
| 00852553007353 | K972333 | 000 |
| 00852553007261 | K972333 | 000 |
| 00852553007216 | K972333 | 000 |
| 00852553007087 | K972333 | 000 |