Cleared Traditional

K954299 - BUHLMANN ANGIOSTENSIN II RIA

K954299 is the FDA 510(k) clearance for BUHLMANN ANGIOSTENSIN II RIA by Buhlmann Laboratories AG. It is a Class 2 Chemistry device (product code CIB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

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

K954299 is an FDA 510(k) clearance for the BUHLMANN ANGIOSTENSIN II RIA. Classified as Radioimmunoassay, Angiotensin I And Renin (product code CIB), Class II - Special Controls.

Submitted by Buhlmann Laboratories AG (Windham, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1085 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Buhlmann Laboratories AG devices

Submission Details

510(k) Number K954299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIB Radioimmunoassay, Angiotensin I And Renin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1085
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIB Radioimmunoassay, Angiotensin I And Renin

All 7
Devices cleared under the same product code (CIB) and FDA review panel - the closest regulatory comparables to K954299.
ACTIVE RENIN IRMA
K061758 · Diagnostic Systems Laboratories, Inc. · Jul 2006
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K011128 · Nichols Institute Diagnostics · Sep 2001
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · Diagnostic Systems Laboratories, Inc. · May 1998
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · Nichols Institute Diagnostics · Jan 1993
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
RENAK
K831694 · Hoffmann-La Roche, Inc. · Jul 1983