Cleared Traditional

K844903 - MIC-BIO-PLATE

K844903 is the FDA 510(k) clearance for MIC-BIO-PLATE by Pasco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K844903 · Pasco Laboratories, Inc. · Microbiology device
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Dec 1984
Decision
10d
Days
Class 2
Risk

K844903 is an FDA 510(k) clearance for the MIC-BIO-PLATE. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on December 24, 1984 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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: 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 Pasco Laboratories, Inc. devices

Submission Details

510(k) Number K844903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date December 24, 1984
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K844903.
SCEPTOR ENTERIC MIC PANEL
K854102 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
SCEPTOR ENTERIC MIC/ID PANEL
K854103 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
PRECEPT TM MEZLOCILLIN
K850833 · Austin Biological Laboratories · Sep 1985
METRONIDAZOLE DISCS
K801805 · G.D. Searle and Co. · Feb 1981