Atlas FDA

GKF

15 FDA 510(k) clearances · Product code

49 daysmedian time to decision
230 days90th percentile
15clearances measured

FDA profile

Official device name
Instrument, Hematocrit, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5600
Medical specialty
Hematology
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RecordFirmDate
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415)Instrumentation Laboratory CO2016-12-14
CRIT-SCAN II MONITOR (K983551)In-Line Diagnostics Corp.1999-05-27
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (K981426)Nova Biomedical Corp.1998-05-12
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (K981425)Nova Biomedical Corp.1998-05-12
STAT PROFILE M ANALYZER (K981427)Nova Biomedical Corp.1998-05-12
MICROSPIN 24 (K953519)Vulcon Technologies1995-11-03
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (K915825)Fisher Scientific Co., LLC1992-03-11
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (K915441)Fisher Scientific Co., LLC1992-01-08
NEW COBE SATURATION/HEMATOCRIT MONITOR (K904336)Cobe Laboratories, Inc.1990-12-27
IONOMETER E-HK AND ACCESSORIES (K880373)Smash Ent., Inc.1988-03-17
CHEMPRO 1000(TM) (K870860)Arden Medical Systems, Inc.1987-04-14
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE (K864646)E.I. Dupont DE Nemours & Co., Inc.1987-01-05
MICROHEMATOCRIT CENTRIFUGE (K864039)Plaza Medical, Inc.1986-10-29
STAT-CRIT HEMATOCRIT MEASURING INSTRU (K802199)United States Surgical, A Division of Tyco Healthc1981-02-04
CUTTER/COMPUR MINI CENTRIFUGE (K781059)Cutter Laboratories, Inc.1978-08-14

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