FDA 510(k) Applications for Medical Device Product Code "KHG"
(Whole Blood Hemoglobin Determination)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K042379 |
BIOSAFE LABORATORIES, INC. |
ANEMIAPRO SELF-SCREENER |
12/15/2004 |
K001462 |
CARESIDE, INC. |
CARESIDE HEMOGLOBIN |
08/21/2000 |
K020138 |
GDS TECHNOLOGY |
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 |
02/11/2002 |
K973649 |
GDS TECHNOLOGY, LLC. |
HEMOSITE TEST SYSTEM |
08/31/1998 |
K994073 |
GDS TECHNOLOGY, LLC. |
HEMOSITE TEST SYSTEM |
01/14/2000 |
K221508 |
Sanguina, Inc. |
AnemoCheck Home |
09/29/2023 |
K163215 |
SANGUINA, LLC |
AnemoCheck |
09/13/2017 |
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