Cleared Traditional

K882095 - MODIFICATION OF BEHRING RAPIMAT II/T

K882095 is an FDA 510(k) clearance for MODIFICATION OF BEHRING RAPIMAT II/T, 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 75-day FDA review.

K882095 · Behring Diagnostics, Inc. · Chemistry device
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Aug 1988
Decision
75d
Days
Class 1
Risk

K882095 is an FDA 510(k) clearance for the MODIFICATION OF BEHRING RAPIMAT II/T. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 75 days - a notably fast clearance 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: 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K882095

510(k) Number K882095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date August 02, 1988
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
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 K882095.
BEHRING TURBITIMER
K883646 · Behring Diagnostics, Inc. · Oct 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988
STAT FAX(TM)
K882938 · Awareness Technology, Inc. · Sep 1988
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc. · Jun 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
PROJECT 300 MICROASSAY BP-12, EIA MINILAB
K873451 · Awareness Technology, Inc. · Nov 1987