The following data is part of a premarket notification filed by Alfa Wassermann, Inc. with the FDA for S-test Ldl Cholesterol (ldl), Model Rc0022.
| Device ID | K091333 |
| 510k Number | K091333 |
| Device Name: | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-06 |
| Decision Date | 2009-08-03 |
| Summary: | summary |