Cleared Traditional

K792087 - MICROFLAME PHOTOMETER

K792087 is an FDA 510(k) clearance for MICROFLAME PHOTOMETER, manufactured by Gilford Instrument Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JJO cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K792087 · Gilford Instrument Laboratories, Inc. · Chemistry device
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Nov 1979
Decision
27d
Days
Class 1
Risk

K792087 is an FDA 510(k) clearance for the MICROFLAME PHOTOMETER. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Gilford Instrument Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - 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 Gilford Instrument Laboratories, Inc. devices

FDA 510(k) Submission Details - K792087

510(k) Number K792087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1979
Decision Date November 13, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JJO Device Classification - Class 1, General Controls

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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 - JJO Flame Emission Photometer For Clinical Use

All 16
Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K792087.
SHABAN #9868 TUBING KIT-9870 STYLET
K832937 · Shaban Mfg. Co. · Oct 1983
IL 943 FLAME PHOTOMETER
K823480 · Instrumentation Laboratory CO · Jan 1983
CORNING 480 FLAME PHOTOMETER
K820631 · Corning Medical & Scientific · Apr 1982
FLAME PHOTOMETER, MODEL 435
K780649 · Corning Medical & Scientific · May 1978
FLAME PHOTOMETER, MODEL 455
K780650 · Corning Medical & Scientific · May 1978
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · Instrumentation Laboratory CO · Oct 1977