Cleared Traditional

K861263 - BEHRING RAPIMAT II

K861263 is the FDA 510(k) clearance for BEHRING RAPIMAT II by Behring Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K861263 · Behring Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
182d
Days
Class 1
Risk

K861263 is an FDA 510(k) clearance for the BEHRING RAPIMAT II. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K861263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1986
Decision Date October 03, 1986
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K861263.
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · Ohmeda Medical · Jan 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
TDX(R) II ANALYZER
K864319 · Abbott Laboratories · Dec 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986