Atlas FDA

KJG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Tube, Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Medical specialty
Pathology
Flags
GMP exempt
Adverse events (MAUDE)
2025: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
24 CELL WELLS TISSUE CULTURE (K823747)Corning Medical & Scientific1983-01-05

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