AnemoCheck
Whole Blood Hemoglobin Determination
SANGUINA, LLC
The following data is part of a premarket notification filed by Sanguina, Llc with the FDA for Anemocheck.
Pre-market Notification Details
| Device ID | K163215 |
| 510k Number | K163215 |
| Device Name: | AnemoCheck |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | SANGUINA, LLC 575 14TH STREET Atlanta, GA 30318 |
| Contact | Erika Tyburski |
| Correspondent | Cathryn N Cambria CAMBRIA REGULATORY CONSULTING , INC. 5536 TROWBRIDGE DR Dunwoody, GA 30338 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-09-13 |
| Summary: | summary |
Trademark Results [AnemoCheck]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANEMOCHECK 86434131 5601518 Live/Registered |
Emory University 2014-10-24 |
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