Cleared Traditional

K875181 - MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (FDA 510(k) Clearance)

K875181 · Marion Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
162d
Days
-
Risk

K875181 is an FDA 510(k) clearance for the MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM.

Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 162 days - an extended review cycle.

This device falls under the Toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marion Laboratories, Inc. devices

Submission Details

510(k) Number K875181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date May 27, 1988
Days to Decision 162 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 87d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -