Cleared Traditional

K880089 - FINNIGAN MAT TSQ-70

K880089 is an FDA 510(k) clearance for FINNIGAN MAT TSQ-70, manufactured by Finnigan Corp.. The device is a Class 1 Chemistry device with product code DOP cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K880089 · Finnigan Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
30d
Days
Class 1
Risk

K880089 is an FDA 510(k) clearance for the FINNIGAN MAT TSQ-70. Classified as Mass Spectrometer, Clinical Use (product code DOP), Class I - General Controls.

Submitted by Finnigan Corp. (San Jose, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2860 - 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 Finnigan Corp. devices

FDA 510(k) Submission Details - K880089

510(k) Number K880089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date February 11, 1988
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

DOP Device Classification - Class 1, General Controls

Product Code DOP Mass Spectrometer, Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2860
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 - DOP Mass Spectrometer, Clinical Use

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