Cleared Traditional

K812604 - BIOVATION URINALYSIS REPORTER

K812604 is an FDA 510(k) clearance for BIOVATION URINALYSIS REPORTER, manufactured by Biovation, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812604 · Biovation, Inc. · Chemistry device
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Oct 1981
Decision
17d
Days
Class 1
Risk

K812604 is an FDA 510(k) clearance for the BIOVATION URINALYSIS REPORTER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Biovation, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 - K812604

510(k) Number K812604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date October 02, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K812604.
715 DELTA TERMINAL
K821058 · Corning Medical & Scientific · May 1982
COMPUTERIZED INTERPRETATION OF ARTERIAL
K820721 · Philip R. Corsello, M.D. · Apr 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · Instrumentation Laboratory CO · Mar 1982
BCD-HPP41C INTERFACE
K810968 · Dynatech Corp. · Apr 1981
DPM CALCULATOR
K810631 · Iso-Data, Inc. · Mar 1981
MICROMEDIC AUTOMATIC COMPUTING CENTER
K803312 · Micomedic Systems · Feb 1981
K812604 · BIOVATION URINALYSIS REPORTER
Download PDF Biovation, Inc.