Cleared Traditional

IRON SYSTEM PACK REAGENTS (K892838) - FDA 510(k) Clearance

Class I Chemistry device.

K892838 · Boehringer Mannheim Corp. · Chemistry device
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Jun 1989
Decision
59d
Days
Class 1
Risk

K892838 is an FDA 510(k) clearance for the IRON SYSTEM PACK REAGENTS. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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

Submission Details

510(k) Number K892838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date June 16, 1989
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

All 21
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K892838.
OLYMPUS IRON REAGENT
K923565 · Olympus Corp. · Sep 1992
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143 · Eastman Kodak Company · Feb 1991
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · Em Diagnostic Systems, Inc. · Oct 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · Em Diagnostic Systems, Inc. · Jun 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · Em Diagnostic Systems, Inc. · Feb 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355 · Eastman Kodak Company · Dec 1988