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Hemoglobin Variants System 250-0001

by Bio-Rad Laboratories

Hemoglobin Variants System 250-0001 (2500001) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K171664 on 13 Sep 2017 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00847817007057), 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) K171664

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 Number00847817007057 UDI-DI Date24 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK171664 Date13 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171664 decided 13 Sep 2017 Active
  • FDA GUDID UDI-DI 00847817007057 listed 24 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171664
  2. Listed FDA GUDID 00847817007057

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hemoglobin Variants System
Generic name
Inherited haemoglobinopathy IVD, reagent
Model / Ref / Catalog
250-0001, 2500001
Primary DI / UDI-DI
00847817007057
510(k) Number
FDA product code
GKA
GMDN term
Inherited haemoglobinopathy IVD, reagent
Device class
Class II
Regulation number
864.7415
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inherited haemoglobinopathy IVD, reagent

Cleared under the same submission (K171664)

and 3 more cleared under K171664

Similar devices

Other devices filed under FDA product code GKA (ABNORMAL HEMOGLOBIN QUANTITATION).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

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