The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech Ldx Alanine Aminotransferase (alt), Model 11-772.
| Device ID | K991834 |
| 510k Number | K991834 |
| Device Name: | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 |
| Classification | Hydrazone Colorimetry, Alt/sgpt |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Thomas E Worthy |
| Correspondent | Thomas E Worthy CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | CKD |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-28 |
| Decision Date | 1999-09-09 |
| Summary: | summary |