Cleared Traditional

K873638 - MICRO-CHEM ANALYZER

K873638 is the FDA 510(k) clearance for MICRO-CHEM ANALYZER by Ocean Scientific, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K873638 · Ocean Scientific, Inc. · Chemistry device
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Sep 1987
Decision
20d
Days
Class 1
Risk

K873638 is an FDA 510(k) clearance for the MICRO-CHEM ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Ocean Scientific, Inc. (Garden Grove, US). The FDA issued a Cleared decision on September 29, 1987 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Ocean Scientific, Inc. devices

Submission Details

510(k) Number K873638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1987
Decision Date September 29, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K873638.
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc. · Jun 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · Dynatech Laboratories, Inc. · Nov 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219 · Gen-Probe, Inc. · Aug 1987
SYVA Q-SPEC PHOTOMETER
K871307 · Syva Co. · May 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · Ciba Corning Diagnostics Corp. · May 1987