Atlas FDA

IDP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Microtome, Cryostat
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Medical specialty
Pathology
Flags
GMP exempt
Adverse events (MAUDE)
2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EXAKT CUTTING & GRINDING SYSTEM (K883514)Exakt Medical Instruments, Inc.1988-08-29

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