ACCESS ULTRASENSITIVE INSULIN ASSAY— 510(k) K953084

Name: FDA 510(k) clearance K953084
Creator: U.S. Food and Drug Administration
Published: 1995-09-25

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K953084 for ACCESS ULTRASENSITIVE INSULIN ASSAY, Substantially Equivalent on 1995-09-25. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code CFP
Device class: Class 1
Regulation: 21 CFR 862.1405
Advisory panel: Clinical Chemistry
Date received: 1995-07-03
Decision date: 1995-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFP

view all

K963911 — ALPCO/MERCODIA INSULIN ELISA1996-11-01
K920109 — IMX INSULIN1992-05-07
K914820 — DSL INSULIN RIA (DSL 1600)1992-01-09
K903628 — AIA-PACK IRI1990-09-07
K901135 — ENZYMUN TEST(R) INSULIN1990-04-03

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
K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software2017-09-13
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

Recalls naming K953084

K-number listed on FDA's recall record

Z-0981-2024 — Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410Class II·Ongoing·Beckman Coulter, Inc.·20231121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953084.

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