Atlas FDA

KER

5 FDA 510(k) clearances · Product code

30 daysmedian time to decision
45 days90th percentile
5clearances measured

FDA profile

Official device name
Container, Embedding
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Medical specialty
Pathology
Flags
GMP exempt
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RecordFirmDate
EMBEDDING RING (K831922)Polymer Technology Corp.1983-07-29
MACLEAN-FOGG, DISP. BASE MOLD (K831900)Polymer Technology Corp.1983-07-28
EMBEDDING RINGS (K831333)Surgipath Medical Industries, Inc.1983-05-25
DISPOSABLE BASE MOLD (K831335)Surgipath Medical Industries, Inc.1983-05-16
LANCER BIOPSY HOLDER (K772149)Sherwood Medical Industries1977-11-22

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