The following data is part of a premarket notification filed by New England Nuclear with the FDA for Ria Kit, Quantitation Of Prostatic Acid.
Device ID | K790817 |
510k Number | K790817 |
Device Name: | RIA KIT, QUANTITATION OF PROSTATIC ACID |
Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFH |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-27 |
Decision Date | 1979-05-07 |