K934064 is an FDA 510(k) clearance for the REFLOTRON HEMOGLOBIN TEST TABS. This device is classified as a Whole Blood Hemoglobin Determination (Class II - Special Controls, product code KHG).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 6, 1993, 159 days after receiving the submission on June 30, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K934064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1993 |
| Decision Date | December 06, 1993 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KHG — Whole Blood Hemoglobin Determination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |