BIO-RAD VARIANT NBS SICKLE CELL PROGRAM— 510(k) K051072

Name: FDA 510(k) clearance K051072
Creator: U.S. Food and Drug Administration
Published: 2005-05-12

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K051072 for BIO-RAD VARIANT NBS SICKLE CELL PROGRAM, Substantially Equivalent on 2005-05-12. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2005-04-26
Decision date: 2005-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKA

view all

K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument2024-04-04
K222635 — Premier Resolution System2023-08-04
K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control2022-04-19
K180762 — CAPI 3 HEMOGLOBIN(E)2018-12-14
K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software2017-09-13

More clearances from Bio-Rad Laboratories, Inc.

view all

K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System2019-02-13
K161687 — D-10 Hemoglobin A1c Program2016-10-14
K151321 — D-100 HbA1c, D-100 HbA1c Calibrator Pack2015-12-09
K142448 — VARIANT II TURBO HbA1c Kit - 2.02015-03-24
K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM2014-06-25

Recalls naming K051072

K-number listed on FDA's recall record

Z-1208-2022 — Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000Class II·Ongoing·Bio-Rad Laboratories, Inc.·20220407

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051072.

Data sourced from openFDA. This site is unofficial and independent of the FDA.