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Reagent, Firefly #395

by Chrono-Log Corp

510(k) K781807

Reagent, Firefly #395 is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K781807 on 22 Nov 1978, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781807 Date22 Nov 1978ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JOZ
FDA applicant
Chrono-Log Corp.
Device class
Class II
Regulation
21 CFR Part 864.5700
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code JOZ (System, Automated Platelet Aggregation).

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