The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Accu-chek(r)complete System/meter & Accu-chek Advantage Test Strips/accu-chek Advantage H Test Strips.
| Device ID | K973662 |
| 510k Number | K973662 |
| Device Name: | ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Mike Flis |
| Correspondent | Mike Flis BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1997-12-15 |
| Summary: | summary |