Cleared Traditional

K842862 - CB FORMALIN (FDA 510(k) Clearance)

Class I Pathology device.

K842862 · Anatech, Ltd. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
36d
Days
Class 1
Risk

K842862 is an FDA 510(k) clearance for the CB FORMALIN. Classified as Solution, Formalin Ammonium Bromide (product code IGE), Class I - General Controls.

Submitted by Anatech, Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - 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 Anatech, Ltd. devices

Submission Details

510(k) Number K842862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date August 28, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 77d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IGE Solution, Formalin Ammonium Bromide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.