Cleared Traditional

K842920 - SAFRANIN, 1% W/V (FDA 510(k) Clearance)

K842920 · E K Ind., Inc. · Pathology device
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Jul 1984
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K842920 is an FDA 510(k) clearance for the SAFRANIN, 1% W/V.

Submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 25, 1984.

This device falls under the Pathology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all E K Ind., Inc. devices

Submission Details

510(k) Number K842920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received July 25, 1984
Decision Date July 25, 1984
Days to Decision -
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -