Cleared Traditional

K896074 - VISION PHENYTOIN

K896074 is an FDA 510(k) clearance for VISION PHENYTOIN, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code DIP cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K896074 · Abbott Laboratories · Chemistry device
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Nov 1989
Decision
29d
Days
Class 2
Risk

K896074 is an FDA 510(k) clearance for the VISION PHENYTOIN. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K896074

510(k) Number K896074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date November 17, 1989
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. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K896074.
QMS TM- PHENYTOIN
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K901080 · Immunotech Corp. · May 1990
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · Syva Co. · Jan 1988
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K870953 · Sigma Diagnostics, Inc. · Mar 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · Em Diagnostic Systems, Inc. · Jan 1987