Cleared Traditional

K812187 - SMITH'S SYSTEMIC FUNGAL MEDIUM

K812187 is the FDA 510(k) clearance for SMITH'S SYSTEMIC FUNGAL MEDIUM by American Scientific Products. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K812187 · American Scientific Products · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
28d
Days
Class 1
Risk

K812187 is an FDA 510(k) clearance for the SMITH'S SYSTEMIC FUNGAL MEDIUM. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 American Scientific Products devices

Submission Details

510(k) Number K812187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date August 31, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 188
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K812187.
EOSIN METHYLENE BLUE AGAR
K820552 · American Laboratory Supply, Inc. · Mar 1982
BILE ESCULIN AZIDE AGAR
K820553 · American Laboratory Supply, Inc. · Mar 1982
SEPTI-CHECK BLOOD CULTURE SLIDE
K812731 · Hoffmann-La Roche, Inc. · Oct 1981
EOSIN METHYLENE BLUE AGAR (LEVINE)
K811642 · Hardy Media · Jul 1981
MACCONKEY AGAR
K811643 · Hardy Media · Jul 1981
HEKTOEN ENTERIC AGAR
K811644 · Hardy Media · Jul 1981