Cleared Traditional

K781644 - ANTIBIOTIC NEPHELOMETER

K781644 is the FDA 510(k) clearance for ANTIBIOTIC NEPHELOMETER by Biovation, Inc.. It is a Class 1 Microbiology device (product code JQX) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K781644 · Biovation, Inc. · Microbiology device
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Oct 1978
Decision
8d
Days
Class 1
Risk

K781644 is an FDA 510(k) clearance for the ANTIBIOTIC NEPHELOMETER. Classified as Nephelometer, For Clinical Use (product code JQX), Class I - General Controls.

Submitted by Biovation, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2700 - 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 Biovation, Inc. devices

Submission Details

510(k) Number K781644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1978
Decision Date October 03, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 102d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQX Nephelometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2700
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 - JQX Nephelometer, For Clinical Use

All 10
Devices cleared under the same product code (JQX) and FDA review panel - the closest regulatory comparables to K781644.
ALBUMIN NEPHELOMETRIC ASSAY
K801362 · J.T. Baker Chemical Co. · Jul 1980
J.T. BAKER NEPHELOMETER
K801089 · J.T. Baker Chemical Co. · May 1980
RAD-291
K781554 · Organon, Inc. · Oct 1978
NEPHELOMETER
K780251 · Kallestad Laboratories, Inc. · Apr 1978
LASER IMMUNONEPHELOMETRIC ANALYZER
K772361 · G.D. Searle and Co. · Jan 1978
TRANSPORTEO MODULE
K771446 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1977