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MeDiCa 0301

by Scimedx Corp.

MeDiCa 0301 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K790295 on 25 May 1979 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545026608), 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) K790295

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 Number00813545026608 UDI-DI Date1 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK790295 Date25 May 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K790295 decided 25 May 1979 Active
  • FDA GUDID UDI-DI 00813545026608 listed 1 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K790295
  2. Listed FDA GUDID 00813545026608

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  • Withdrawn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
Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
0301
Primary DI / UDI-DI
00813545026608
510(k) Number
FDA product code
DBM
GMDN term
Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5090
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay

Cleared under the same submission (K790295)

and 3 more cleared under K790295

Similar devices

Other devices filed under FDA product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control).

Other devices from Scimedx Corp.

See all devices from Scimedx Corp. →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)