The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech Ldx Aspartate Aminotransferase (ast).
| Device ID | K032027 |
| 510k Number | K032027 |
| Device Name: | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) |
| Classification | Hydrazone Colorimetry, Ast/sgot |
| 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 | CIS |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-01 |
| Decision Date | 2003-09-05 |
| Summary: | summary |