Cleared Traditional

ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)

K970126 · Bio-Rad Laboratories, Inc. · Chemistry
Feb 1997
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K970126 is an FDA 510(k) clearance for the ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545), a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 25, 1997, 42 days after receiving the submission on January 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K970126 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 1997
Decision Date February 25, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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