Atlas FDA

JJC

32 FDA 510(k) clearances · Product code

58 daysmedian time to decision
113 days90th percentile
32clearances measured

FDA profile

Official device name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2150
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2008: 4 · 2009: 62 · 2010: 41 · 2011: 22 · 2013: 8 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AVL OMNI ANALYZER (K945915)Avl Scientific Corp.1995-04-05
NOVA 16 ANALYZER (K945584)Nova Biomedical Corp.1995-02-08
OPERA SYSTEM (K943376)Miles, Inc.1994-09-14
TECHNICON RA-2000(TM) SYSTEM (K901410)Technicon Instruments Corp.1990-07-17
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (K901141)Baxter Healthcare Corp1990-04-09
RFA/2 RAPID FLOW ANALYZER W/COMPUTER (K890332)Alpkem Corp.1989-02-17
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (K881056)American Research Products Co.1988-11-15
TECHNICON SMAC 3 SYSTEM (K875105)Technicon Instruments Corp.1988-02-16
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998)Technicon Instruments Corp.1987-05-26
TECHNICON RA-XT SYSTEM WITH ANALYTES (K862561)Technicon Instruments Corp.1986-10-20
TECHNICON RA-500 SYSTEM (K854345)Technicon Instruments Corp.1985-11-26
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS (K852306)Methodist Hospital of Memphis1985-08-02
LANCER ANALYZER CUPS (K833157)Sherwood Medical Co.1983-12-08
TECHNICON RA-1000 SYSTEM (K833023)Technicon Instruments Corp.1983-11-03
SBA 300 CLINICAL CHEMISTRY ANALYZER (K823233)Gilford Instrument Laboratories, Inc.1982-11-29
TECHNICON RA 1000 SYSTEM (K813077)Technicon Corp.1981-11-16
TECHNICON SMAC II SYSTEM & ACCESSORIES (K811249)Technicon Instruments Corp.1981-05-21
PRE-VAP CAPS (K810394)Sherman Boosalis1981-03-06
BMC RIAFLO SYSTEM (K801481)Boehringer Mannheim Corp.1980-08-20
NSI WASH SOLUTION CONCENTRATE (K800587)Nobel Scientific Industries, Inc.1980-08-08
PHOTOVOLT PVA 4M+2 ANALYZER (K800453)Photovolt Corp.1980-03-20
TECHNICON C800 SYSTEM (K792285)Technicon Instruments Corp.1979-12-06
TECHNICON STAT/LYTE ISE ELECTROLYTE (K781503)Technicon Instruments Corp.1978-09-27
AUTOMATIC ANALYZER (K771662)Lachat Chemicals, Inc.1977-12-06
SMA II (K771336)Technicon Instruments Corp.1977-08-26
IN VITRO DIAGNOSTIC REAGENTS (K770506)Norwood Scientific Associates, Inc.1977-05-06
SMA MICROLYZER (K761342)Technicon Instruments Corp.1977-02-01
REAGENTS (K761086)Simmler & Son, Inc.1977-01-12
SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY (K760749)Gilford Instrument Laboratories, Inc.1976-12-29
MT II - TEST FOR CONTINUOUS FLOW ANAL (K761165)Technicon Instruments Corp.1976-12-13
LANCER AUTOANALYZER MANIFOLD PUMP TUB (K760622)Sherwood Medical Industries1976-11-24
ANALYZER, GLUCOSE/UREA/CREATININE (K760211)Instrumentation Laboratory CO1976-08-26

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