Cleared Traditional

K842002 - HANKS BALANCED SALTS-HBSS H2387

K842002 is the FDA 510(k) clearance for HANKS BALANCED SALTS-HBSS H2387 by Sigma Chemical Co.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K842002 · Sigma Chemical Co. · Pathology device
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Jun 1984
Decision
37d
Days
Class 1
Risk

K842002 is an FDA 510(k) clearance for the HANKS BALANCED SALTS-HBSS H2387. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Sigma Chemical Co. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K842002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date June 22, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 77d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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 - KIT Media And Components, Synthetic Cell And Tissue Culture

All 304
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K842002.
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