Cleared Traditional

K800057 - MICRO ELISA MINI READER

K800057 is the FDA 510(k) clearance for MICRO ELISA MINI READER by Dynatech Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K800057 · Dynatech Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1980
Decision
32d
Days
Class 1
Risk

K800057 is an FDA 510(k) clearance for the MICRO ELISA MINI READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on February 11, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Dynatech Laboratories, Inc. devices

Submission Details

510(k) Number K800057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1980
Decision Date February 11, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K800057.
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · Miles Laboratories, Inc. · Jun 1980
MICRO ELISA AUTO READER
K800522 · Dynatech Laboratories, Inc. · Mar 1980
MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.
K800523 · Varian Assoc., Inc. · Mar 1980
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · Miles Laboratories, Inc. · Dec 1979
MANUAL MICRO ELISA READER #2-530
K791302 · Dynatech Laboratories, Inc. · Aug 1979
CARY 210 SERIES, SPECTROPHOTOMETER
K791102 · Varian Assoc., Inc. · Jul 1979