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Colorgene Hsv DNA Hybridization Test

by Enzo Biochem, Inc. 510(k)

Active United States

510(k) K880604

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880604 Date3 Aug 1988ClearedStatusActive

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  • Withdrawn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
GQN
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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