The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Jas Hdl Cholesterol (automated) Reagent.
| Device ID | K021671 |
| 510k Number | K021671 |
| Device Name: | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | LBS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-21 |
| Decision Date | 2002-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274022856 | K021671 | 000 |
| 00817274022252 | K021671 | 000 |
| 00817274021705 | K021671 | 000 |
| 00817274021699 | K021671 | 000 |
| 00817274021682 | K021671 | 000 |
| 00817274021675 | K021671 | 000 |