Cleared Traditional

K780114 - IMMUNOZYME E. HISTOLYTICA ANTIGENS (FDA 510(k) Clearance)

K780114 · Millipore Corp. · Microbiology device
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Apr 1978
Decision
86d
Days
-
Risk

K780114 is an FDA 510(k) clearance for the IMMUNOZYME E. HISTOLYTICA ANTIGENS.

Submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978 after a review of 86 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.

View all Millipore Corp. devices

Submission Details

510(k) Number K780114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1978
Decision Date April 19, 1978
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -