Cleared Traditional

K781734 - SODIUM CHLORIDE, 0.85% (FDA 510(k) Clearance)

K781734 · Bioscientific · Chemistry device
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Oct 1978
Decision
12d
Days
-
Risk

K781734 is an FDA 510(k) clearance for the SODIUM CHLORIDE, 0.85%.

Submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 12 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 Bioscientific devices

Submission Details

510(k) Number K781734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1978
Decision Date October 24, 1978
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -