Cleared Traditional

K853284 - MYREADER 7

K853284 is an FDA 510(k) clearance for MYREADER 7, manufactured by Scientific Sales Intl., Inc.. The device is a Class 1 Microbiology device with product code JJQ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K853284 · Scientific Sales Intl., Inc. · Microbiology device
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Oct 1985
Decision
60d
Days
Class 1
Risk

K853284 is an FDA 510(k) clearance for the MYREADER 7. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2300 - the FDA microbiology device 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 Scientific Sales Intl., Inc. devices

FDA 510(k) Submission Details - K853284

510(k) Number K853284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date October 04, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K853284.
TERUMO SENSIBEAD EIA COLORIMETER
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