The following data is part of a premarket notification filed by Bioprocessing, Inc. with the FDA for Liquitrol-tm, Tumor Marker Control, Level 1 And 2.
| Device ID | K961359 |
| 510k Number | K961359 |
| Device Name: | LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOPROCESSING, INC. 18 MUSSEY RD. Scarborough, ME 04074 |
| Contact | Gary Goodrich |
| Correspondent | Gary Goodrich BIOPROCESSING, INC. 18 MUSSEY RD. Scarborough, ME 04074 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-09-13 |