Cleared Traditional

DOWFLOW ALT-UV DETERMINATION (K821536) - FDA 510(k) Clearance

Class I Chemistry device.

K821536 · The Dow Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
21d
Days
Class 1
Risk

K821536 is an FDA 510(k) clearance for the DOWFLOW ALT-UV DETERMINATION. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K821536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1982
Decision Date June 14, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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 - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 32
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K821536.
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · Sigma Chemical Co. · Aug 1984
ALT ENZYME ASSAY KIT
K821946 · Travenol Laboratories, S.A. · Jul 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805 · Boehringer Mannheim Corp. · Jul 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048 · Beckman Instruments, Inc. · May 1982
ALT-QUANTICHROM
K812926 · Abbott Laboratories · Nov 1981
ALT (UV) TEST
K810355 · Boehringer Mannheim Corp. · Feb 1981