Cleared Traditional

K781081 - EMIT MCA PROGRAM TAPE

K781081 is the FDA 510(k) clearance for EMIT MCA PROGRAM TAPE by Instrumentation Laboratory CO. It is a Class 1 Toxicology device (product code JQP) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K781081 · Instrumentation Laboratory CO · Toxicology device
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Sep 1978
Decision
92d
Days
Class 1
Risk

K781081 is an FDA 510(k) clearance for the EMIT MCA PROGRAM TAPE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2100 - the FDA toxicology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K781081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1978
Decision Date September 27, 1978
Days to Decision 92 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 87d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 46
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K781081.
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories · May 1979
UNION CARBIDE CORP. COMPUTER INTERFACE
K790336 · Union Carbide Corp. · Apr 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · Kallestad Laboratories, Inc. · Jan 1979
COMPUTER INTERFACE IL 814
K781173 · Instrumentation Laboratory CO · Sep 1978
DATA TERMINAL MODEL 722
K781217 · Corning Medical & Scientific · Aug 1978
EMIT CLINICAL PROCESSOR - CP 5000
K780881 · Syva Co. · Jun 1978