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Adtemp™ 413BQ

by American Diagnostic Corporation

Adtemp™ 413BQ is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K940686 on 8 Jul 1994 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00634782082987), active as of 23 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 23 Oct 2026

Documents

510(k) K940686

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782082987 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK940686 Date8 Jul 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K940686 decided 8 Jul 1994 Active
  • FDA GUDID UDI-DI 00634782082987 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K940686
  2. Listed FDA GUDID 00634782082987

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Adtemp™
Generic name
Intermittent electronic patient thermometer
Model / Ref / Catalog
413BQ
Primary DI / UDI-DI
00634782082987
510(k) Number
FDA product code
FLL
GMDN term
Intermittent electronic patient thermometer
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)