The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Stratus Fluorometric Enzyme Immun0-.
Device ID | K830301 |
510k Number | K830301 |
Device Name: | STRATUS FLUOROMETRIC ENZYME IMMUN0- |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-28 |
Decision Date | 1983-02-25 |