Cleared Traditional

K780074 - LDH-L REAGENT SET (FDA 510(k) Clearance)

K780074 · Medical Analysis Systems, Inc. · Chemistry device
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Feb 1978
Decision
28d
Days
-
Risk

K780074 is an FDA 510(k) clearance for the LDH-L REAGENT SET.

Submitted by Medical Analysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K780074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1978
Decision Date February 13, 1978
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -