Cleared Traditional

SERONORM LIPID (K771437) - FDA 510(k) Clearance

Class I Chemistry device.

K771437 · Nyegaard & Co. A/S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
32d
Days
Class 1
Risk

K771437 is an FDA 510(k) clearance for the SERONORM LIPID. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), 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 K771437 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 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 K771437.
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