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C-Terminal Pth Ria Kit

by Diagnostic Systems Laboratories, Inc. 510(k)

Active United States

510(k) K853784

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853784 Date4 Oct 1985ClearedStatusActive

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  • Withdrawn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
CEW
Device Class
Class II
Regulation
21 CFR Part 862.1545
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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