Cleared Traditional

K820199 - FETALSCREEN

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

FDA 510(k) Submission Details - K820199

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -