The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Microalbustix Reagent Strips.
| Device ID | K982219 |
| 510k Number | K982219 |
| Device Name: | MICROALBUSTIX REAGENT STRIPS |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-24 |
| Decision Date | 1998-08-12 |
| Summary: | summary |