Cleared Traditional

K870836 - ATAC 1500 CHEMISTRY ANALYZER

K870836 is the FDA 510(k) clearance for ATAC 1500 CHEMISTRY ANALYZER by Turpen Laboratory Systems, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K870836 · Turpen Laboratory Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
29d
Days
Class 1
Risk

K870836 is an FDA 510(k) clearance for the ATAC 1500 CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Turpen Laboratory Systems, Inc. (Lakewood, US). The FDA issued a Cleared decision on April 1, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Turpen Laboratory Systems, Inc. devices

Submission Details

510(k) Number K870836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date April 01, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 143
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K870836.
KODAK EKTACHEM 700S ANALYZER
K872103 · Eastman Kodak Company · Jun 1987
KODAK EKTACHEM 700P ANALYZER
K872104 · Eastman Kodak Company · Jun 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833 · Ciba Corning Diagnostics Corp. · Apr 1987
AFFINITY(TM) SYSTEM
K865105 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1986
IQ IMMUNOCHEMISTRY SYSTEM
K863531 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986