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Hematology and Pathology devices.

21 CFR Part 864 · 4,454 FDA 510(k) clearances

Regulations
111
Product codes
285
Devices
4,454
Device class distribution
Class I
1,327 (29.8%)
Class II
3,127 (70.2%)
Top product codes by device count
CodeExample deviceDevices
GKZ Athelas Home 379
KIT AMNIO-GROW TM 367
LCP Nova Allegro HbA1c Assay, Nova Allegro Analyzer 249
JPK XN-L CHECK 192
GGP CRYOcheck Chromogenic Factor VIII 190
JPA STA Satellite Max® 181
KIR FRESH CELLS NCI H292 170
GKL Glocyte Automated Cell Counter System 130
GJS CoaguChek XS Plus System 127
GGN VALIDATE D-Dimer Calibration Verification / Linearity Test Kit 99
KHE Instant-view-PLUS immunochemical Fecal Occult Blood Test 97
GJT CRYOcheck Factor VIII Deficient Plasma with VWF 79
DAP HemosIL D-Dimer HS 500 57
JBQ INNOVANCE Antithrombin 56
GFO HemosIL Silica Clotting Time 52
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