Cleared Traditional

K781081 - EMIT MCA PROGRAM TAPE

K781081 is an FDA 510(k) clearance for EMIT MCA PROGRAM TAPE, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Toxicology device with 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

FDA 510(k) Submission Details - K781081

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.

JQP Device Classification - Class 1, General Controls

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 55
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