Cleared Traditional

K852976 - NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC (FDA 510(k) Clearance)

K852976 · American Micro Scan · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all American Micro Scan devices

Submission Details

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
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -