Cleared Traditional

K852834 - ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L (FDA 510(k) Clearance)

K852834 · Ortho Diagnostic Systems, Inc. · Hematology device
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Aug 1985
Decision
37d
Days
-
Risk

K852834 is an FDA 510(k) clearance for the ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on August 8, 1985 after a review of 37 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.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K852834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1985
Decision Date August 08, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 113d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -