The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Gelman Triphor Control.
| Device ID | K850202 |
| 510k Number | K850202 |
| Device Name: | GELMAN TRIPHOR CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Harwood Green |
| Correspondent | Harwood Green GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-02-06 |