Atlas FDA

HYF

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Giemsa Stain
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Medical specialty
Hematology
Flags
GMP exempt
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Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.

RecordFirmDateBuilder
GIEMSA STAIN (K842742)E K Ind., Inc.1984-08-15+ Add
QUICK STAIN WRIGHT'S GIEMSA W/BUFF (K833677)J.S. Medical Assoc.1983-11-25+ Add
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (K833665)J.S. Medical Assoc.1983-11-25+ Add
CASE WRIGHT-GIEMSA STAIN PAK (K831131)Case Instruments1983-06-08+ Add

Track HYF automatically

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