Cleared Traditional

K800887 - HYPNOTICS PLUS SALICYLATE TX CONTROL

K800887 is the FDA 510(k) clearance for HYPNOTICS PLUS SALICYLATE TX CONTROL by Utak Laboratories, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K800887 · Utak Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
12d
Days
Class 1
Risk

K800887 is an FDA 510(k) clearance for the HYPNOTICS PLUS SALICYLATE TX CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Utak Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980 after a review of 12 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 Utak Laboratories, Inc. devices

Submission Details

510(k) Number K800887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1980
Decision Date April 29, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 87d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K800887.
DIGOXIN & PHENYTOIN CONTROL SERA
K803097 · Amersham Corp. · 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
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC
K780960 · Vitek Systems, Inc. · Dec 1978