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Rotaclone Rotavirus Diagnostic Kit

by Cambridge Bioscience Corp. 510(k)

Active United States

510(k) K852969

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852969 Date5 Nov 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0552-2022 FDA Class II initiated 1 Dec 2021

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

Specification

510(k)

510(k) Number
FDA Product Code
LIQ
Device Class
Class I
Regulation
21 CFR Part 866.3405
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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