The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Stratec Lia Ii Analyzer.
| Device ID | K961142 |
| 510k Number | K961142 |
| Device Name: | STRATEC LIA II ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | David D Smith |
| Correspondent | David D Smith NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1997-02-18 |