Cleared Traditional

K843569 - PRECISET AMMONIA

K843569 is an FDA 510(k) clearance for PRECISET AMMONIA, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843569 · Boehringer Mannheim Corp. · Chemistry device
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Sep 1984
Decision
18d
Days
Class 1
Risk

K843569 is an FDA 510(k) clearance for the PRECISET AMMONIA. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 18 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K843569

510(k) Number K843569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date September 28, 1984
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 381
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K843569.
SUGAR-CHEX
K851042 · Streck Laboratories, Inc. · Apr 1985
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K851043 · Streck Laboratories, Inc. · Apr 1985
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K851079 · Beckman Instruments, Inc. · Apr 1985
CHEM TRAK LIQUID BILIRUBIN CONTROL
K833097 · Medical Analysis Systems, Inc. · Jan 1984
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · Quantimetrix Corp. · Jul 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · Pharmacia, Inc. · Apr 1983