The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Liquid Scintillation Counter.
Device ID | K780179 |
510k Number | K780179 |
Device Name: | LIQUID SCINTILLATION COUNTER |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | ROCHE MEDICAL ELECTRONICS, INC. 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 | 1978-02-03 |
Decision Date | 1978-02-23 |