The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for 5stratec Sl 300 Lia-mat.
| Device ID | K950029 |
| 510k Number | K950029 |
| Device Name: | 5STRATEC SL 300 LIA-MAT |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Joanne Pilot |
| Correspondent | Joanne Pilot NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-04 |
| Decision Date | 1995-08-02 |