Cleared Traditional

K843645 - SYSTEMATE A AMYLASE HEM 67204

K843645 is the FDA 510(k) clearance for SYSTEMATE A AMYLASE HEM 67204 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K843645 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1984
Decision
11d
Days
Class 2
Risk

K843645 is an FDA 510(k) clearance for the SYSTEMATE A AMYLASE HEM 67204. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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 K843645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date September 28, 1984
Days to Decision 11 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
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIJ Saccharogenic, Amylase

All 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K843645.
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951 · Behring Diagnostics, Inc. · Jan 1986
X-AMYLASE ASSAY KIT
K852636 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053 · Coulter Electronics, Inc. · Feb 1984
DADE COLORIMETRIC AMYLASE
K813529 · American Dade · Dec 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
K812594 · Harleco · Oct 1981