Cleared Traditional

K832397 - HYBRITECH 405-500 NM FILTER MODULE

K832397 is an FDA 510(k) clearance for HYBRITECH 405-500 NM FILTER MODULE, manufactured by Hybritech, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K832397 · Hybritech, Inc. · Chemistry device
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Aug 1983
Decision
42d
Days
Class 1
Risk

K832397 is an FDA 510(k) clearance for the HYBRITECH 405-500 NM FILTER MODULE. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 42 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.

FDA 510(k) Submission Details - K832397

510(k) Number K832397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1983
Decision Date August 31, 1983
Days to Decision 42 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
47d faster than avg
Panel avg: 89d · This submission: 42d
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 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K832397.
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K832364 · Hybritech, Inc. · Aug 1983
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K832206 · Abbott Diagnostics · Aug 1983
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · Varian Assoc., Inc. · Jul 1983
K832397 · HYBRITECH 405-500 NM FILTER MODULE
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