Cleared Traditional

K781506 - MIC-BIO-PLATE

K781506 is the FDA 510(k) clearance for MIC-BIO-PLATE by Pasco Laboratories, Inc.. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K781506 · Pasco Laboratories, Inc. · Microbiology device
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Oct 1978
Decision
84d
Days
Class 1
Risk

K781506 is an FDA 510(k) clearance for the MIC-BIO-PLATE. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Pasco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 K781506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1978
Decision Date October 17, 1978
Days to Decision 84 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
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSF Culture Media, Single Biochemical Test

All 57
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K781506.
SIMMONS CITRATE AGAR
K791474 · Isle Media and Sterile Products, Inc. · Sep 1979
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K791476 · Isle Media and Sterile Products, Inc. · Sep 1979
LOMBARD-DOWELL GLUCOSE AGAR
K790626 · Anaerobe Systems · Apr 1979
MIC-2000
K780907 · Gibco Laboratories Life Technologies, Inc. · Jun 1978
PRE-REDUCED MEDIA
K780533 · Gibco Laboratories Life Technologies, Inc. · Apr 1978