Cleared Traditional

K962113 - ANTHOS PHACTS VERSION MICROPLATE READER

K962113 is an FDA 510(k) clearance for ANTHOS PHACTS VERSION MICROPLATE READER, manufactured by Columbia Bioscience, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K962113 · Columbia Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
158d
Days
Class 1
Risk

K962113 is an FDA 510(k) clearance for the ANTHOS PHACTS VERSION MICROPLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Columbia Bioscience, Inc. (Frederick, US). The FDA issued a Cleared decision on November 5, 1996 after a review of 158 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.

FDA 510(k) Submission Details - K962113

510(k) Number K962113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date November 05, 1996
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
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 209
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K962113 · ANTHOS PHACTS VERSION MICROPLATE READER
Download PDF FDA Summary Columbia Bioscience, …