The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Pal Luminometer.
Device ID | K903911 |
510k Number | K903911 |
Device Name: | GEN-PROBE PAL LUMINOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Contact | Ruben Chairez |
Correspondent | Ruben Chairez GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-24 |
Decision Date | 1990-10-04 |