Cleared Traditional

K820199 - FETALSCREEN (FDA 510(k) Clearance)

K820199 · Ortho Diagnostic Systems, Inc. · Hematology device
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May 1982
Decision
106d
Days
-
Risk

K820199 is an FDA 510(k) clearance for the FETALSCREEN.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on May 12, 1982 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K820199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1982
Decision Date May 12, 1982
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -