Cleared Traditional

BUHLMANN ANGIOSTENSIN II RIA

K954299 · Buhlmann Laboratories AG · Chemistry
Oct 1995
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K954299 is an FDA 510(k) clearance for the BUHLMANN ANGIOSTENSIN II RIA, a Radioimmunoassay, Angiotensin I And Renin (Class II — Special Controls, product code CIB), submitted by Buhlmann Laboratories AG (Windham, US). The FDA issued a Cleared decision on October 19, 1995, 35 days after receiving the submission on September 14, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1085.

Submission Details

510(k) Number K954299 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1995
Decision Date October 19, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIB — Radioimmunoassay, Angiotensin I And Renin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1085

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