The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Dca 2000 + Microalbumin/creatinine Assay.
| Device ID | K963142 |
| 510k Number | K963142 |
| Device Name: | DCA 2000 + MICROALBUMIN/CREATININE ASSAY |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46514 -0070 |
| Contact | Rosanne M Savol, R.a.c. |
| Correspondent | Rosanne M Savol, R.a.c. BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46514 -0070 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-13 |
| Decision Date | 1996-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414535722 | K963142 | 000 |
| 00630414532790 | K963142 | 000 |
| 00630414027364 | K963142 | 000 |