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AccuMed AC-AT2102

by Amcrest Industries LLC

AccuMed AC-AT2102 is a Class II device made by Amcrest Industries LLC, cleared under FDA 510(k) K130231 on 15 Oct 2013 and listed in FDA GUDID since 13 Jun 2017 (UDI-DI 00854509005802), 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) K130231

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 Number00854509005802 UDI-DI Date13 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK130231 Date15 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130231 decided 15 Oct 2013 Active
  • FDA GUDID UDI-DI 00854509005802 listed 13 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130231
  2. Listed FDA GUDID 00854509005802

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AccuMed
Generic name
Infrared patient thermometer, skin
Model / reference
AC-AT2102
Primary DI / UDI-DI
00854509005802
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Infrared patient thermometer, skin.

Other devices from Amcrest Industries LLC

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)