The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech Bun/creatinine Test System.
| Device ID | K972012 |
| 510k Number | K972012 |
| Device Name: | CHOLESTECH BUN/CREATININE TEST SYSTEM |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Gary Hewett |
| Correspondent | Gary Hewett CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-07-24 |