Cleared Traditional

K800832 - VIRAL CULTURETTE HANK'S BAL. SALT SOL.

K800832 is the FDA 510(k) clearance for VIRAL CULTURETTE HANK'S BAL. SALT SOL. by Marion Health & Safety, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K800832 · Marion Health & Safety, Inc. · Microbiology device
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May 1980
Decision
36d
Days
Class 1
Risk

K800832 is an FDA 510(k) clearance for the VIRAL CULTURETTE HANK'S BAL. SALT SOL.. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Marion Health & Safety, Inc. (Walker, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Marion Health & Safety, Inc. devices

Submission Details

510(k) Number K800832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1980
Decision Date May 20, 1980
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K800832.
STERILE SALINE 0.85%
K834315 · Hardy Media · Jan 1984
WATER W/TWEEN 80
K834316 · Hardy Media · Jan 1984
VIRAL TRANSPORT MED. (46-995-04)
K802303 · Flow Laboratories, Inc. · Oct 1980
PARA-PAK (C&S)
K792712 · Meridian Diagnostics, Inc. · Jan 1980
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL
K791543 · Isle Media and Sterile Products, Inc. · Sep 1979
TRANSPORT MEDIUM AMIES
K791545 · Isle Media and Sterile Products, Inc. · Sep 1979