Cleared Traditional

BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (K942245) - FDA 510(k) Clearance

Class I Microbiology device.

K942245 · Biowhittaker Molecular Applications, Inc. · Microbiology device
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Apr 1995
Decision
329d
Days
Class 1
Risk

K942245 is an FDA 510(k) clearance for the BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2300 - the FDA microbiology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biowhittaker Molecular Applications, Inc. devices

Submission Details

510(k) Number K942245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date April 03, 1995
Days to Decision 329 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 102d · This submission: 329d
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 257
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