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CRYOcheck™ Reference Control Normal RCN-10

by Precision Biologic

CRYOcheck™ Reference Control Normal RCN-10 is a Class II device made by Precision Biologic, cleared under FDA 510(k) K013708 on 10 Dec 2001 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00843876000060), 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) K013708

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 Number00843876000060 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013708 Date10 Dec 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013708 decided 10 Dec 2001 Active
  • FDA GUDID UDI-DI 00843876000060 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013708
  2. Listed FDA GUDID 00843876000060

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CRYOcheck™ Reference Control Normal
Generic name
Multiple coagulation marker IVD, control
Model / reference
RCN-10
Primary DI / UDI-DI
00843876000060
510(k) Number
FDA product code
GIZ
GMDN term
Multiple coagulation marker IVD, control
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple coagulation factor IVD, control

Cleared under the same submission (K013708)

Similar devices in this category

Other devices filed under Multiple coagulation factor IVD, control.

Other devices from Precision Biologic

See all devices from Precision Biologic →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)