Cleared Traditional

K780147 - ISOENZYME SERUM CONTROL

K780147 is the FDA 510(k) clearance for ISOENZYME SERUM CONTROL by Corning Medical & Scientific. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K780147 · Corning Medical & Scientific · Chemistry device

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Feb 1978

Decision

24d

Days

Class 1

Risk

K780147 is an FDA 510(k) clearance for the ISOENZYME SERUM CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Corning Medical & Scientific (Walker, US). The FDA issued a Cleared decision on February 23, 1978 after a review of 24 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 Corning Medical & Scientific devices

Submission Details

510(k) Number	K780147 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 1978
Decision Date	February 23, 1978
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

64d faster than avg

Panel avg: 88d · This submission: 24d

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 58

Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K780147.

ISOZYME - ID CPK MARKER

K780801 · Dade, Baxter Travenol Diagnostics, Inc. · Jun 1978

CLIN. CHEM. CONTROL SERUM-QUANTITATE

K780554 · Beckman Instruments, Inc. · Jun 1978

CHEMISTRY CONTROL & REFERENCE SERUMS

K780204 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978

ACA GLUTAMYL TRANSFERASE

K771800 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977

CARDIOZYME CK-CONTROL LEVEL 1

K771740 · Dade, Baxter Travenol Diagnostics, Inc. · Oct 1977

CARDIOZYME CK-CONTROL ABNORMAL

K770971 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K780147

Corning Medical & Scientific

Walker, MI · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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