Cleared Traditional

K944361 - DOCUMENT R AMMONIA/ETHANOL CONTROL

K944361 is the FDA 510(k) clearance for DOCUMENT R AMMONIA/ETHANOL CONTROL by Casco Standards. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K944361 · Casco Standards · Chemistry device
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Nov 1994
Decision
84d
Days
Class 1
Risk

K944361 is an FDA 510(k) clearance for the DOCUMENT R AMMONIA/ETHANOL CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Casco Standards devices

Submission Details

510(k) Number K944361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date November 30, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 371
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K944361.
REP CHOLESTEROL PROFILE CONTROL
K950590 · Helena Laboratories · Mar 1995
SAS QUANT HCG SERUM
K944785 · Sa Scientific, Inc. · Jan 1995
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
K945718 · Casco Standards · Jan 1995
QUANTITATE URIC ACID VERIFIER SET
K944453 · Beckman Instruments, Inc. · Nov 1994
SAS QUANT HCG URINE
K944891 · Sa Scientific, Inc. · Nov 1994
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
K944338 · Casco Standards · Nov 1994