Cleared Traditional

K760356 - DISH, STERILE DISPOSABLE POLYSTYRENE

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

FDA 510(k) Submission Details - K760356

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -