Cleared Traditional

K852976 - NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC

K852976 · American Micro Scan · Microbiology device
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Dec 1985
Decision
142d
Days
-
Risk

K852976 is an FDA 510(k) clearance for the NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC.

Submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 142 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.

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FDA 510(k) Submission Details - K852976

510(k) Number K852976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date December 04, 1985
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -