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Cmv Brite Turbo Kit

by Biotest Diagnostics Corp. 510(k)

Active United States

510(k) K991650

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK991650 Date12 Jul 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LIN
Device Class
Class II
Regulation
21 CFR Part 866.3175
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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