The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Accu-chek A1c Hemoglobin Test.
| Device ID | K974491 |
| 510k Number | K974491 |
| Device Name: | ACCU-CHEK A1C HEMOGLOBIN TEST |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-28 |
| Decision Date | 1998-05-13 |
| Summary: | summary |