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CRYOcheck Hex LA

by Precision Biologic

CRYOcheck Hex LA is a Class II device made by Precision Biologic, cleared under FDA 510(k) K193556 on 23 Oct 2020 and listed in FDA GUDID since 5 Nov 2020 (UDI-DI 00843876000510), 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) K193556

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 Number00843876000510 UDI-DI Date5 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193556 Date23 Oct 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193556 decided 23 Oct 2020 Active
  • FDA GUDID UDI-DI 00843876000510 listed 5 Nov 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193556
  2. Listed FDA GUDID 00843876000510

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Lupus anticoagulant marker IVD, kit, clotting
Model / Ref / Catalog
Hex LA
Primary DI / UDI-DI
00843876000510
510(k) Number
FDA product code
GFO
GMDN term
Lupus anticoagulant marker IVD, kit, clotting
Device class
Class II
Regulation number
864.7925
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lupus anticoagulant marker IVD, kit, clotting

Cleared under the same submission (K193556)

Other devices from Precision Biologic

See all devices from Precision Biologic →

Properties

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