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MeDiCa 1001-48

by Scimedx Corp.

MeDiCa 1001-48 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K782048 on 17 Jan 1979 and listed in FDA GUDID since 4 Nov 2020 (UDI-DI 00813545026905), 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) K782048

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 Number00813545026905 UDI-DI Date4 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK782048 Date17 Jan 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K782048 decided 17 Jan 1979 Active
  • FDA GUDID UDI-DI 00813545026905 listed 4 Nov 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K782048
  2. Listed FDA GUDID 00813545026905

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  • Withdrawn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 antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
1001-48
Primary DI / UDI-DI
00813545026905
510(k) Number
FDA product code
DHN
GMDN term
Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Cleared under the same submission (K782048)

Similar devices in this category

Other devices filed under Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay.

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)