The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb Ultrobact (tm) Pneumococcus Kit; 2321-110.
| Device ID | K862848 |
| 510k Number | K862848 |
| Device Name: | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 |
| Classification | Antisera, All Types, Streptococcus Pneumoniae |
| Applicant | LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Contact | Ed Zior |
| Correspondent | Ed Zior LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Product Code | GWC |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-12-18 |