Cleared Traditional

K875181 - MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM

K875181 · Marion Laboratories, Inc. · Toxicology device
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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

FDA 510(k) Submission Details - K875181

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 87d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -