The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Clinitek Microalbumin Reagent Strips.
| Device ID | K972706 |
| 510k Number | K972706 |
| Device Name: | CLINITEK MICROALBUMIN REAGENT STRIPS |
| Classification | Tetrabromo-m-cresolsulfonphthalein, Albumin |
| 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 | CJG |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414548951 | K972706 | 000 |