The following data is part of a premarket notification filed by Los Alamos Diagnostics with the FDA for Lad Model 735 Luminometer.
Device ID | K874262 |
510k Number | K874262 |
Device Name: | LAD MODEL 735 LUMINOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | LOS ALAMOS DIAGNOSTICS P.O. BOX 1221 2470 EAST ROAD Los Alamos, NM 87544 |
Contact | Betty Strietelmeier |
Correspondent | Betty Strietelmeier 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 | 1987-10-20 |
Decision Date | 1987-11-27 |