VARIANT II B-THALASSEMIA— 510(k) K991127

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K991127 for VARIANT II B-THALASSEMIA, Substantially Equivalent on 1999-06-10. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 1999-04-02
Decision date: 1999-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL1992-08-25

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Recalls naming K991127

K-number listed on FDA's recall record

Z-1537-2014 — Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.Class II·Terminated·Bio-Rad Laboratories, Inc.·20140408

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991127.

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