The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Reflotron Hemoglobin Test Tabs.
| Device ID | K934064 |
| 510k Number | K934064 |
| Device Name: | REFLOTRON HEMOGLOBIN TEST TABS |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Michael L Flis |
| Correspondent | Michael L Flis BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-30 |
| Decision Date | 1993-12-06 |