Cleared Traditional

K872120 - SERALYZER III BLOOD CHEMISTRY ANALYZER

K872120 is an FDA 510(k) clearance for SERALYZER III BLOOD CHEMISTRY ANALYZER, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K872120 · Miles Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
149d
Days
Class 1
Risk

K872120 is an FDA 510(k) clearance for the SERALYZER III BLOOD CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K872120

510(k) Number K872120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date October 28, 1987
Days to Decision 149 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 slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 44
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K872120.
SYVA(R) ETS(R) PLUS SYSTEM
K903357 · Syva Co. · Sep 1990
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · Olympus Corp. · Aug 1989
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020 · Alpkem Corp. · Sep 1988
(FPIA) ASSAY BUFFER
K871486 · Windsor Laboratories, Inc. · May 1987
SYVA ETS SYSTEM
K863245 · Syva Co. · Mar 1987
OLYMPUS PK300
K864834 · Olympus Corp. · Feb 1987