Cleared Traditional

PATHONORM H & L (K771439) - FDA 510(k) Clearance

Class I Chemistry device.

K771439 · Nyegaard & Co. A/S · Chemistry device
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Sep 1977
Decision
32d
Days
Class 1
Risk

K771439 is an FDA 510(k) clearance for the PATHONORM H & L. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Nyegaard & Co. A/S (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 32 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 Nyegaard & Co. A/S devices

Submission Details

510(k) Number K771439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 02, 1977
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
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 - JJT Enzyme Controls (assayed And Unassayed)

All 31
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K771439.
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
CLIN. CHEM. CONTROL SERUM-QUANTITATE
K780554 · Beckman Instruments, Inc. · Jun 1978
ACA GLUTAMYL TRANSFERASE
K771800 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
LDH ISOTROL T
K770049 · Sigma Chemical Co. · Jan 1977