Cleared Traditional

K900788 - MODIFIED APSARA CLINICAL DIAGNOSTIC ANA...

K900788 is the FDA 510(k) clearance for MODIFIED APSARA CLINICAL DIAGNOSTIC ANA... by Datachem, Inc.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K900788 · Datachem, Inc. · Chemistry device
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Jul 1990
Decision
135d
Days
Class 2
Risk

K900788 is an FDA 510(k) clearance for the MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Datachem, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 5, 1990 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Datachem, Inc. devices

Submission Details

510(k) Number K900788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date July 05, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEM Electrode, Ion Specific, Potassium

All 58
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K900788.
NOVA 5 NA/K/C1 ALALYZER
K915177 · Nova Biomedical Corp. · Jan 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · Nova Biomedical Corp. · Jan 1992
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991
IONOMETER EH
K901039 · Fresenius USA, Inc. · Jun 1990
IONOMETER EH-HK AND ACCESSORIES
K901041 · Fresenius USA, Inc. · Jun 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · Baxter Healthcare Corp · Mar 1990