Cleared Traditional

K843051 - WRIGHTS STAIN SOLUTION

K843051 · Reagent Laboratory, Inc. · Pathology device
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Aug 1984
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K843051 is an FDA 510(k) clearance for the WRIGHTS STAIN SOLUTION.

Submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 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 Reagent Laboratory, Inc. devices

FDA 510(k) Submission Details - K843051

510(k) Number K843051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received August 03, 1984
Decision Date August 03, 1984
Days to Decision -
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -