The following data is part of a premarket notification filed by New England Nuclear with the FDA for Atomlight (liquid Scintillation Solution.
Device ID | K801245 |
510k Number | K801245 |
Device Name: | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJJ |
CFR Regulation Number | 862.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-27 |
Decision Date | 1980-06-20 |