The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Ldl-direct Controls.
| Device ID | K902740 |
| 510k Number | K902740 |
| Device Name: | LDL-DIRECT CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Janet Perkins |
| Correspondent | Janet Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-22 |
| Decision Date | 1990-12-07 |