Cleared Traditional

ARS, CHEMISTRY (K791313) - FDA 510(k) Clearance

Class I Chemistry device.

K791313 · Mid Tech, Inc. · Chemistry device
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Aug 1979
Decision
35d
Days
Class 1
Risk

K791313 is an FDA 510(k) clearance for the ARS, CHEMISTRY. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Mid Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Mid Tech, Inc. devices

Submission Details

510(k) Number K791313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date August 16, 1979
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 184
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K791313.
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813 · Diagnostic Products Corp. · Apr 1980
LIPOTROL
K792024 · Helena Laboratories · Oct 1979
LYOPHILIZED HDL CHOLESTEROL CONTROLS
K792025 · Helena Laboratories · Oct 1979
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · Sigma Chemical Co. · Dec 1978
COMP. CLIN. CHEM. CONTROL SERUM-DECISION
K780552 · Beckman Instruments, Inc. · May 1978
CHEMISTRY CONTROL-LOW & HIGH TQC TM
K770380 · Technicon Instruments Corp. · Apr 1977