Cleared Traditional

K803097 - DIGOXIN & PHENYTOIN CONTROL SERA

K803097 is an FDA 510(k) clearance for DIGOXIN & PHENYTOIN CONTROL SERA, manufactured by Amersham Corp.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K803097 · Amersham Corp. · Toxicology device
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Dec 1980
Decision
14d
Days
Class 1
Risk

K803097 is an FDA 510(k) clearance for the DIGOXIN & PHENYTOIN CONTROL SERA. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device 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 Amersham Corp. devices

FDA 510(k) Submission Details - K803097

510(k) Number K803097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date December 22, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 148
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K803097.
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1981
PROFILE CARDIAC SET ASSAYED SERUM CONTR.
K803036 · General Diagnostics · Dec 1980
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.
K803039 · General Diagnostics · Dec 1980
BECKMAN ICS DRUG CONTROL SERA
K802854 · Beckman Instruments, Inc. · Dec 1980
CARDIOACTIVE DRUGS CONTROL
K802672 · Fisher Scientific Co., LLC · Nov 1980
THERA CHEM
K782128 · Fisher Scientific Co., LLC · Mar 1979