The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Boehringer Mannheim/ Hitachi 911 Analyzer.
| Device ID | K921661 |
| 510k Number | K921661 |
| Device Name: | BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | John Stevens |
| Correspondent | John Stevens 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 | 1992-04-07 |
| Decision Date | 1992-06-30 |