The following data is part of a premarket notification filed by Los Alamos Diagnostics with the FDA for Modified Model 535(tm) Luminometer.
| Device ID | K896117 |
| 510k Number | K896117 |
| Device Name: | MODIFIED MODEL 535(TM) LUMINOMETER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | LOS ALAMOS DIAGNOSTICS P.O. BOX 1221 2470 EAST ROAD Los Alamos, NM 87544 |
| Contact | Ross U Robinson |
| Correspondent | Ross U Robinson LOS ALAMOS DIAGNOSTICS P.O. BOX 1221 2470 EAST ROAD Los Alamos, NM 87544 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1989-11-30 |