Cleared Traditional

K873436 - EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95

K873436 is the FDA 510(k) clearance for EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K873436 · Em Diagnostic Systems, Inc. · Chemistry device
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Oct 1987
Decision
63d
Days
Class 2
Risk

K873436 is an FDA 510(k) clearance for the EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95. 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 October 29, 1987 after a review of 63 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K873436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date October 29, 1987
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 Chemistry 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 K873436.
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135 · Syva Co. · Apr 1988
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · Em Diagnostic Systems, Inc. · Nov 1987
ETHANOL CALIBRATOR
K872181 · American Monitor Corp. · Jul 1987
DIGOXIN FPIA CALIBRATORS
K872328 · Sigma Chemical Co. · Jul 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · Sigma Diagnostics, Inc. · Jun 1987