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Cva 291713

by Streck

Cva 291713 is a Class II device made by Streck, cleared under FDA 510(k) K960557 on 3 Apr 1996 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00844509001430), 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) K960557

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 Number00844509001430 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK960557 Date3 Apr 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K960557 decided 3 Apr 1996 Active
  • FDA GUDID UDI-DI 00844509001430 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K960557
  2. Listed FDA GUDID 00844509001430

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cva
Generic name
Full blood count IVD, control
Model / Ref / Catalog
291713
Primary DI / UDI-DI
00844509001430
FDA product code
JPK
GMDN term
Full blood count IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3.0 Milliliter

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K960557)

and 8 more cleared under K960557

Similar devices in this category

Other devices filed under Full blood count IVD, control.

Other devices from Streck

See all devices from Streck →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)