The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Sy/l, M, And H.
| Device ID | K941912 |
| 510k Number | K941912 |
| Device Name: | N/T PROTEIN CONTROL SY/L, M, AND H |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BEHRING DIAGNOSTICS, INC. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen BEHRING DIAGNOSTICS, INC. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-06-16 |