Cleared Traditional

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR (K771033) - FDA 510(k) Clearance

Class I Chemistry device.

K771033 · Mid Tech, Inc. · Chemistry device
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Aug 1977
Decision
56d
Days
Class 1
Risk

K771033 is an FDA 510(k) clearance for the SMAC SYS., SUPPLEMENTAL PRODUCTS FOR. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Mid Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K771033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1977
Decision Date August 04, 1977
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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.