
Associates of Cape Cod, Inc.
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Fungitell STAT is an FDA 510(k)-cleared medical device (K191167) manufactured by Associates of Cape Cod, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2019. Regulation: 8.

ADC
SKU DX606933

MDF
SKU DX683863

3M Littmann
SKU DX771242

Welch Allyn
SKU DX297280