The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Therachem-plus, Tri-level Tdc (tm).
| Device ID | K861185 |
| 510k Number | K861185 |
| Device Name: | THERACHEM-PLUS, TRI-LEVEL TDC (TM) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-05-23 |