The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Chality Control Material (assayed & Unassayed).
| Device ID | K913133 |
| 510k Number | K913133 |
| Device Name: | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Contact | Bruce R.williams |
| Correspondent | Bruce R.williams BIONOSTICS, INC. TWO CRAIG RD. Acton, MA 01720 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1991-09-27 |