The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tina-quant Hemoglobin A1c.
| Device ID | K934070 |
| 510k Number | K934070 |
| Device Name: | TINA-QUANT HEMOGLOBIN A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | John D Stevens |
| Correspondent | John D Stevens BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 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 | 1993-08-20 |
| Decision Date | 1994-10-11 |