Atlas FDA

IBJ

9 FDA 510(k) clearances · Product code

82 daysmedian time to decision
161 days90th percentile
9clearances measured

FDA profile

Official device name
Light, Microscope
Device class
Class I (low risk)
Regulation
21 CFR 864.3600
Medical specialty
Pathology
Flags
GMP exempt
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RecordFirmDate
VIDEO ANALYZER 4000 (K874750)Scientific Imaging, Inc.1988-04-25
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (K874207)Intl. Remote Imaging Systems1988-01-05
CELL COUNTING GRID GRATICULE (K874190)Portable Medical Laboratories, Inc.1988-01-05
MCARTHUR MICROSCOPE, STANDARD METAL VERSION (K864049)Portable Medical Laboratories, Inc.1986-10-29
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (K854735)Portable Medical Laboratories, Inc.1985-12-10
PATHOLOGY INSTRUMENTATION & ACCESSORIES (K823040)Iris Remote Imaging Systems1983-01-14
2XC MICROSCOPE (K822207)Amarel Precision Instruments, Inc.1982-08-05
A O MICROSCOPE VIDEO SYSTEM (K821865)Warner-Lambert Co.1982-07-14
PULLEN POCKET SCOPE (K802818)P.A. Research Corp.1981-04-17

Track IBJ automatically

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