Cleared Traditional

K821184 - SPIN CHEM REAGENTS & STANDARDS

K821184 is an FDA 510(k) clearance for SPIN CHEM REAGENTS & STANDARDS, manufactured by Smithkline Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K821184 · Smithkline Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
27d
Days
Class 1
Risk

K821184 is an FDA 510(k) clearance for the SPIN CHEM REAGENTS & STANDARDS. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 27 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 Smithkline Diagnostics, Inc. devices

FDA 510(k) Submission Details - K821184

510(k) Number K821184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 24, 1982
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

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 61
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K821184.
PARAMAX IRON BLANK REAGENT
K841887 · American Dade · Jun 1984
SERUM IRON & TIBC#65084 & 65085
K833017 · Emd Chemicals, Inc. · Nov 1983
SERUM IRON-PTF-600
K831201 · American Monitor Corp. · May 1983
SERUM IRON REAGENT SET
K812840 · Anco Medical Reagents & Assoc. · Dec 1981
DIRECT IRON REAGENT SET
K812777 · The Dow Chemical Co. · Oct 1981
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · Diagnostic Solutions, Inc. · May 1980