The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Laser Prealbumin Test.
| Device ID | K851912 |
| 510k Number | K851912 |
| Device Name: | LASER PREALBUMIN TEST |
| Classification | Prealbumin, Antigen, Antiserum, Control |
| Applicant | BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Product Code | JZJ |
| CFR Regulation Number | 866.5060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-01 |
| Decision Date | 1985-06-21 |