The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Rai-trol Fructosamine Serum Controls I And Ii.
| Device ID | K922904 |
| 510k Number | K922904 |
| Device Name: | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-16 |
| Decision Date | 1992-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238011032 | K922904 | 000 |
| 00817238010783 | K922904 | 000 |