The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog Number 1730347.
| Device ID | K983503 |
| 510k Number | K983503 |
| Device Name: | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Jennifer L Tribbett |
| Correspondent | Jennifer L Tribbett BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-06 |
| Decision Date | 1998-12-01 |
| Summary: | summary |