Atlas FDA

JJG

30 FDA 510(k) clearances · Product code

47 daysmedian time to decision
104 days90th percentile
30clearances measured

FDA profile

Official device name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2140
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
1999: 1 · 2020: 86 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AG CHEMISTRY ANALYZER SYSTEM (K972409)Landmark Scientific, Inc.1997-08-28
PICCOLO(TM) (K942782)Abaxis, Inc.1995-03-13
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (K934592)Abaxis, Inc.1994-04-06
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942)Olympus Corp.1992-06-10
COBAS ALPHA (K910222)Roche Diagnostic Systems, Inc.1991-02-27
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (K903626)Beckman Instruments, Inc.1990-10-15
COBAS FARA II CENTRIFUGAL ANALYZER (K893854)Roche Diagnostic Systems, Inc.1989-08-03
COBAS FARA CENTRIFUGAL ANALYZER (K893641)Roche Diagnostic Systems, Inc.1989-07-20
TECHNICON DAX(TM) SYSTEM (K885203)Technicon Instruments Corp.1989-03-28
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973)Instrumentation Laboratory CO1987-06-11
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838)Beckman Instruments, Inc.1987-05-26
ANALYST PHYSICIAN'S OFFICE PROFILER (K854523)E.I. Dupont DE Nemours & Co., Inc.1986-01-08
I.C.L.S. COMPULYZER (K854055)Integrated Computerized Laboratory Systems, Inc.1985-11-19
GEN PROFILER SYSTEM (K851619)Electro-Cucleonics, Inc.1985-05-14
COBAS FLUORESCENCE POLARIZATION MODULE (K843914)Roche Diagnostic Systems, Inc.1984-11-27
PDA SYSTEM (K842522)Abbott Laboratories1984-08-02
DISPOSABLE CUVETTE ARRAY (K840231)Consumable Lab Supplies1984-03-22
ENCORE CHEMISTRY ANALYZER (K832716)Baker Instructions Corp.1983-10-04
ROTOR (K831571)American Scientific Products1983-06-30
REAGENT CUPS (K831569)American Scientific Products1983-06-30
ENCORE CHEMISTRY ANALYZER (K830641)Baker Instructions Corp.1983-04-05
FLEXIGRAM AUTO LOADER SYSTEM (K811525)Electro-Nucleonics Laboratories, Inc.1981-06-18
CENTRIFICHEM SYSTEM 500 ANALYZER (K801139)Union Carbide Corp.1980-06-09
IL MODEL 773 FLUORESCENCE LIGHT SCATTER (K801026)Instrumentation Laboratory CO1980-05-28
COBAS-BIO CENTRIFUGAL ANALYZER (K792671)Hoffmann-La Roche, Inc.1980-01-17
CENTRIFICHEM SYSTEM 500 (K791180)Union Carbide Corp.1979-08-10
CENTRIA SYSTEM (K790550)Union Carbide Corp.1979-05-07
ANALYZER, CENTRIFUCHEM SYSTEM 400 (K790278)Union Carbide Corp.1979-04-04
ANALYZER, AUTOMED CENTRIFUGAL (K781900)Autogenic Systems1978-12-20
CENTRIFICHEM SYS 400 ANALYZER (K771813)Clinical Diagnostics, Inc.1977-10-25

Track JJG automatically

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