The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Fructosamine Abg21 Test System.
| Device ID | K913614 |
| 510k Number | K913614 |
| Device Name: | FRUCTOSAMINE ABG21 TEST SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | John D Stevens |
| Correspondent | John D Stevens 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 | 1991-08-13 |
| Decision Date | 1991-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630908196 | K913614 | 000 |
| 04015630912063 | K913614 | 000 |