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Osmometer Model Om-6010

by Fiske Med Science

510(k) K811179

Osmometer Model Om-6010 is a Class I device made by Fiske Med Science, cleared under FDA 510(k) K811179 on 15 May 1981, 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 NumberK811179 Date15 May 1981ClearedStatusActive

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  • Withdrawn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
JJM
Device class
Class I
Regulation
21 CFR Part 862.2730
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code JJM (Osmometer For Clinical Use).