Atlas FDA

LJG

27 FDA 510(k) clearances · Product code

32 daysmedian time to decision
45 days90th percentile
27clearances measured

FDA profile

Official device name
Quality Control Slides
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
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RecordFirmDate
MICROSPORIDIUM CONTROL SET (K943228)Meridian Diagnostics, Inc.1994-10-27
MICROSPORIDIUM CONTROL SLIDE (K924893)Scientific Device Laboratory, Inc.1993-01-15
GRAM STAIN CONTROL SLIDE (K890718)Scientific Device Laboratory, Inc.1989-03-16
CRYPTOSPORIDIUM CONTROL SLIDE (K890670)Scientific Device Laboratory, Inc.1989-03-16
BION DIRECT IDENTIFICATION CONTROL SLIDE (K890616)Bion Ent., Ltd.1989-02-17
HISTO-CHECK FUNGAL CONTROL SLIDES (K883570)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK LEGIONELLA CONTROL SLIDES (K883567)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK GRAM NEGATIVE SLIDES (K883569)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK PARASITIC CONTROL SLIDES (K883571)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK ACID FAST SLIDES (K883568)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK SLIDES (K883208)Val Tech Diagnostics, Inc.1988-08-25
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES (K881106)Sigma Diagnostics, Inc.1988-04-21
SPIROCHETES HISTOLOGY CONTROL SLIDES (K881109)Sigma Diagnostics, Inc.1988-04-21
FUNGI HISTOLOGY CONTROL SLIDES (K881112)Sigma Diagnostics, Inc.1988-04-21
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES (K881108)Sigma Diagnostics, Inc.1988-04-12
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES (K881110)Sigma Diagnostics, Inc.1988-04-12
INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES (K881107)Sigma Diagnostics, Inc.1988-03-30
ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES (K880962)Alpha-Tec Systems, Inc.1988-03-30
INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL (K881111)Sigma Diagnostics, Inc.1988-03-30
ACID FAST BACILLI STAIN CONTROL (K840515)Scientific Device Laboratory, Inc.1984-03-09
PROTOZOA STAIN CONTROL (K840517)Scientific Device Laboratory, Inc.1984-03-09
METACHROMATIC GRANULE STAIN CONTROL (K840516)Scientific Device Laboratory, Inc.1984-03-09
Q-CHECK REAGENT STANDARDS (K830134)Lab Ability, Inc.1983-01-09
ATS AFB STAIN CONTROL SLIDE (K823706)Alpha-Tec Systems, Inc.1983-01-07
ATS GRAM STAIN CONTROL SLIDE (K823704)Alpha-Tec Systems, Inc.1983-01-07
ATS PARASITOLOGY STAIN CONTROL SLIDE (K823705)Alpha-Tec Systems, Inc.1983-01-07
ACID FAST QUALITY CONTROL SLIDES (K822604)Medastat Scientific Corp.1982-09-28

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