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Serum, Blood Urea Nitiogen

by Fisher Scientific Co., LLC 510(k)

Active United States

510(k) K781885

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781885 Date20 Dec 1978ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CDW
Device Class
Class II
Regulation
21 CFR Part 862.1770
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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