Cleared Traditional

K822960 - MICROFLUOR B PLATE & MICRO FLUOR W PLATE

K822960 is an FDA 510(k) clearance for MICROFLUOR B PLATE & MICRO FLUOR W PLATE, manufactured by Dynatech Corp.. The device is a Class 1 Chemistry device with product code LIB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K822960 · Dynatech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1982
Decision
42d
Days
Class 1
Risk

K822960 is an FDA 510(k) clearance for the MICROFLUOR B PLATE & MICRO FLUOR W PLATE. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - 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 Corp. devices

FDA 510(k) Submission Details - K822960

510(k) Number K822960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1982
Decision Date November 16, 1982
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 29
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K822960.
HANDI-WASH
K823787 · Dynatech Corp. · Mar 1983
MICRO STIX #011-010-5000 & HOLDER#5100
K823833 · Dynatech Corp. · Mar 1983
REMOVAWELL PLATE LID
K823557 · Dynatech Corp. · Dec 1982
MICROFLUOR B REMOVAWELL STRIPS
K822962 · Dynatech Corp. · Nov 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292 · American Dade · Aug 1982
CALI-LOOP
K820345 · Carr-Scarborough Microbiologicals, Inc. · Mar 1982