Cleared Traditional

FLUSHING SOLUTION (K823283) - FDA 510(k) Clearance

K823283 · Nobel Scientific Industries, Inc. · Hematology device
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Dec 1982
Decision
29d
Days
-
Risk

K823283 is an FDA 510(k) clearance for the FLUSHING SOLUTION.

Submitted by Nobel Scientific Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology 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 K823283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1982
Decision Date December 03, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -