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MeDiCa 8034-96

by Scimedx Corp.

MeDiCa 8034-96 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K831100 on 4 May 1983 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545027582), 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) K831100

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 Number00813545027582 UDI-DI Date1 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK831100 Date4 May 1983DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K831100 decided 4 May 1983 Active
  • FDA GUDID UDI-DI 00813545027582 listed 1 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K831100
  2. Listed FDA GUDID 00813545027582

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  • Withdrawn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
Smooth muscle antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
8034-96
Primary DI / UDI-DI
00813545027582
510(k) Number
FDA product code
DBL
GMDN term
Smooth muscle antibody IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayMitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassaySmooth muscle antibody IVD, kit, fluorescent immunoassayIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

Cleared under the same submission (K831100)

and 8 more cleared under K831100

Similar devices

Other devices filed under FDA product code DBL (Multiple Autoantibodies, 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)