Atlas FDA

LIB

43 FDA 510(k) clearances · Product code

35 daysmedian time to decision
89 days90th percentile
43clearances measured

FDA profile

Official device name
Device, General Purpose, Microbiology, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (K023677)Osmetech2003-01-29
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (K920416)Behring Diagnostics, Inc.1992-04-08
GULL ELISAWARE (K912558)Gull Laboratories, Inc.1991-09-16
CORNING EASY WASH ELISA PLATES (K872273)Corning Medical & Scientific1987-07-07
CELL LIFTER (K871559)Corning Costar Corp.1987-05-15
NORMAL SALINE STERILE (K864249)Mds Laboratories, Inc.1987-03-31
CORNING ELISA PLATES (K863789)Corning Medical & Scientific1986-10-03
MICROSCOPE SLIDES (K862112)Abco Dealers, Inc.1986-06-13
AUTO MASH (K854604)Dynatech Corp.1985-12-06
MULTI MASH 2000 (K854603)Dynatech Corp.1985-12-06
MINI MASH 2000 (K854602)Dynatech Corp.1985-12-06
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES (K854423)Dynatech Laboratories, Inc.1985-11-20
MYWASHER 5 (K853285)Scientific Sales Intl., Inc.1985-10-04
MIC-CONCEPT VIEWBOX (K853745)Microtech Medical Systems, Inc.1985-09-19
QUADRA TITER MICRO PLATES (K850725)Microtech Medical Systems, Inc.1985-04-30
PORTABLE DIAGNOSTIC LABORATORY (K844476)Portable Medical Laboratories, Inc.1985-03-13
RAPID DIAGNOSTIC KIT (K844442)Portable Medical Laboratories, Inc.1985-02-01
HAND-HELD SLIDE READER (K844473)Portable Medical Laboratories, Inc.1985-01-04
PHARMA-PLAST PETRI DISH (K843483)Zimmar Consulting , Ltd.1984-09-21
GIARDIA GUARD (K842052)Gelman Sciences, Inc.1984-09-11
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS (K842057)Polymer Technology Corp.1984-06-07
CODE-A-WELL SERIES 200 PLATE (K841632)Plastic Injectors, Inc.1984-05-25
CODE-A-WELL SERIES 300 PLATE (K841937)Plastic Injectors, Inc.1984-05-22
CODE-A-WELL (K841390)Plastic Injectors, Inc.1984-05-02
HCC-MYCOBACTERIA STAIN KIT (K833131)Dr. C.V. Jacob1983-10-27
READER MICROELISA SYSTEM (K831641)Organon Teknika Corp.1983-08-11
IMMULON SUBSTRATE REMOVAWELL STRIPS (K832117)Dynatech Corp.1983-08-08
MICROELISA COMP (K831658)Organon Teknika Corp.1983-07-26
HEATING BLOCK MICROELISA SYSTEM (K831642)Organon Teknika Corp.1983-07-26
STRIPREADER MICROELISA SYSTEM (K831643)Organon Teknika Corp.1983-07-26
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS (K831448)R&D Systems, Inc.1983-06-08
DISPOSABLE STERILE FILTER SYSTEM (K831450)Corning Medical & Scientific1983-06-02
HANDI-WASH (K823787)Dynatech Corp.1983-03-09
MICRO STIX #011-010-5000 & HOLDER#5100 (K823833)Dynatech Corp.1983-03-08
REMOVAWELL PLATE LID (K823557)Dynatech Corp.1982-12-28
MICROFLUOR B PLATE & MICRO FLUOR W PLATE (K822960)Dynatech Corp.1982-11-16
MICROFLUOR B REMOVAWELL STRIPS (K822962)Dynatech Corp.1982-11-16
DISPOSABLE DISPENSING-SPREAD PIPETS (K822292)American Dade1982-08-25
CALI-PIPETTE (K820346)Carr-Scarborough Microbiologicals, Inc.1982-03-04
CALI-LOOP (K820345)Carr-Scarborough Microbiologicals, Inc.1982-03-04
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY (K820043)American Dade1982-01-28
MINIWASH II (K813640)Dynatech Corp.1982-01-28
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (K812068)Hexcel Medical1981-09-08

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