Atlas FDA

HYK

7 FDA 510(k) clearances · Product code

22 daysmedian time to decision
50 days90th percentile
7clearances measured

FDA profile

Official device name
Hematoxylin Harris'S
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Medical specialty
Hematology
Flags
GMP exempt
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RecordFirmDate
INSTANT HEMATOXYLIN (K873107)Shandon, Inc.1987-08-21
HARRIS HEMATOXYLIN (K872498)Anatech, Ltd.1987-07-09
HARRIS HEMATOXYLIN, MERCURY FREE, ACID (K843425)Accra Laboratories, Inc.1984-10-02
HARRIS HEMATOXYLIN (K823328)Accra Laboratories, Inc.1982-12-28
HARRIS HEMATOXYLIN (K810733)Surgipath1981-04-14
VOLU-SOL HARRIS HEMATOXYLIN (K800324)Volu Sol Medical Industries1980-02-22
HEMATOXYLIN STAIN HARRIS (K781585)Bioscientific1978-10-10

Track HYK automatically

Every clearance here is in the API, with alerts when new ones post.