Cleared Traditional

K861263 - BEHRING RAPIMAT II

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

K861263 · Behring Diagnostics, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K861263

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.

JJQ Device Classification - Class 1, General Controls

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 165
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K861263.
TERUMO OVATION SPECTROPHOTOMETER
K864285 · Terumo Medical Corp. · Jan 1987
AP1 COLORIMETER
K864634 · Awareness Technology, Inc. · Dec 1986
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