The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Rai-trol Elevated Lipids Control.
| Device ID | K915191 |
| 510k Number | K915191 |
| Device Name: | RAI-TROL ELEVATED LIPIDS CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Peacock, Jr. |
| Correspondent | Peacock, Jr. REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-19 |
| Decision Date | 1991-12-18 |