The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Hitachi 717 Chemistry Analyzer.
Device ID | K872494 |
510k Number | K872494 |
Device Name: | HITACHI 717 CHEMISTRY ANALYZER |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
Contact | Cheri Emmons |
Correspondent | Cheri Emmons BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-24 |
Decision Date | 1987-07-09 |