Cleared Traditional

K833027 - HAEMOPHILUS/NEISSERIA IDENTIF-PANEL (FDA 510(k) Clearance)

K833027 · American Micro Scan · Microbiology device
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Oct 1983
Decision
51d
Days
-
Risk

K833027 is an FDA 510(k) clearance for the HAEMOPHILUS/NEISSERIA IDENTIF-PANEL.

Submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K833027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1983
Decision Date October 28, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -