Cleared Traditional

K781576 - MINI-KEM

K781576 is the FDA 510(k) clearance for MINI-KEM by Coulter Electronics, Inc.. It is a Class 1 Toxicology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K781576 · Coulter Electronics, Inc. · Toxicology device
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Oct 1978
Decision
18d
Days
Class 1
Risk

K781576 is an FDA 510(k) clearance for the MINI-KEM. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2300 - 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K781576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1978
Decision Date October 03, 1978
Days to Decision 18 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
69d faster than avg
Panel avg: 87d · This submission: 18d
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 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K781576.
MULTISKAN (78-503-00)
K790422 · Flow Laboratories, Inc. · Apr 1979
HEMESPEC
K782035 · Helena Laboratories · Jan 1979
UROTRON
K781632 · Boehringer Mannheim Corp. · Dec 1978
SPECTROPHOTOMETER
K781138 · Bausch & Lomb, Inc. · Aug 1978
UNISTAT BILIRUBINOMETER
K781241 · American Optical Corp. · Aug 1978
FISHER SPECTROPHOTOMETER
K780902 · Bausch & Lomb, Inc. · Jun 1978