Skip to content

Architect 1P36-27

by Abbott

Architect 1P36-27 (01P3627) is a carbamazepine therapeutic drug monitoring IVD (FDA Class II) made by Abbott, cleared under FDA 510(k) K103627 on 14 Oct 2011 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740081072), 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) K103627

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 Number00380740081072 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103627 Date14 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103627 decided 14 Oct 2011 Active
  • FDA GUDID UDI-DI 00380740081072 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103627
  2. Listed FDA GUDID 00380740081072

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Architect
Generic name
Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
1P36-27, 01P3627
Primary DI / UDI-DI
00380740081072
510(k) Number
FDA product code
KLT, DKB
GMDN term
Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
862.3645, 862.3200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K103627)

Similar devices

Other devices filed under FDA product code KLT (ENZYME IMMUNOASSAY, CARBAMAZEPINE).

Other devices from Abbott

See all devices from Abbott →

Properties

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