Cleared Traditional

K874101 - EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #6...

K874101 is the FDA 510(k) clearance for EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #6... by Em Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K874101 · Em Diagnostic Systems, Inc. · Toxicology device
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Nov 1987
Decision
32d
Days
Class 2
Risk

K874101 is an FDA 510(k) clearance for the EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on November 9, 1987 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K874101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1987
Decision Date November 09, 1987
Days to Decision 32 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
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K874101.
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · Syva Co. · Oct 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · Em Diagnostic Systems, Inc. · May 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135 · Syva Co. · Apr 1988
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · Em Diagnostic Systems, Inc. · Oct 1987
ETHANOL CALIBRATOR
K872181 · American Monitor Corp. · Jul 1987