The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Multi Analyte Linearity Set.
| Device ID | K936245 |
| 510k Number | K936245 |
| Device Name: | MULTI ANALYTE LINEARITY SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K.c. Chen, Ph D. |
| Correspondent | K.c. Chen, Ph D. TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-10-04 |