Cleared Traditional

K780351 - NORMAL UNASSAYED CONTROL SERA

K780351 is the FDA 510(k) clearance for NORMAL UNASSAYED CONTROL SERA by Macomb Chemical Co.. It is a Class 1 Hematology device (product code JJY) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K780351 · Macomb Chemical Co. · Hematology device
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Apr 1978
Decision
52d
Days
Class 1
Risk

K780351 is an FDA 510(k) clearance for the NORMAL UNASSAYED CONTROL SERA. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1978 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - the FDA hematology device 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K780351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1978
Decision Date April 24, 1978
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 113d · This submission: 52d
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 478
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K780351.
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · Sigma Chemical Co. · Dec 1978
RIA CONTROLS
K781593 · Dade, Baxter Travenol Diagnostics, Inc. · Oct 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
CHEMISTRY CONTROL, NORMAL
K770310 · Icn Pharmaceuticals, Inc. · Apr 1977
CHEMISTRY CONTROL, ABNORMAL
K770312 · Icn Pharmaceuticals, Inc. · Apr 1977