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 |