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MeDiCa 0608-MI

by Scimedx Corp.

MeDiCa 0608-MI is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K843343 on 22 Oct 1984 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545026738), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K843343

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813545026738 UDI-DI Date1 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK843343 Date22 Oct 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K843343 decided 22 Oct 1984 Active
  • FDA GUDID UDI-DI 00813545026738 listed 1 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K843343
  2. Listed FDA GUDID 00813545026738

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MeDiCa
Generic name
Multiple thyroid antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
0608-MI
Primary DI / UDI-DI
00813545026738
510(k) Number
FDA product code
JZO
GMDN term
Multiple thyroid antibody IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple thyroid antibody IVD, kit, fluorescent immunoassay

Cleared under the same submission (K843343)

and 3 more cleared under K843343

Similar devices

Other devices filed under FDA product code JZO (System, Test, Thyroid Autoantibody).

Other devices from Scimedx Corp.

See all devices from Scimedx Corp. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)