Cleared Traditional

DISH, STERILE DISPOSABLE POLYSTYRENE (K760356) - FDA 510(k) Clearance

K760356 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Nov 1976
Decision
99d
Days
-
Risk

K760356 is an FDA 510(k) clearance for the DISH, STERILE DISPOSABLE POLYSTYRENE.

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1976 after a review of 99 days - within the typical 510(k) review window.

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

View all Gibco Laboratories Life Technologies, Inc. devices

Submission Details

510(k) Number K760356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1976
Decision Date November 09, 1976
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -