Cleared Traditional

K953066 - SERODIA ATG

K953066 is an FDA 510(k) clearance for SERODIA ATG, manufactured by Fujirebio America, Inc.. The device is a Class 2 Immunology device with product code DDC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K953066 · Fujirebio America, Inc. · Immunology device
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Aug 1995
Decision
45d
Days
Class 2
Risk

K953066 is an FDA 510(k) clearance for the SERODIA ATG. Classified as Thyroglobulin, Antigen, Antiserum, Control (product code DDC), Class II - Special Controls.

Submitted by Fujirebio America, Inc. (West Cadwell, US). The FDA issued a Cleared decision on August 14, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology device framework. 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 Fujirebio America, Inc. devices

FDA 510(k) Submission Details - K953066

510(k) Number K953066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date August 14, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 105d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDC Device Classification - Class 2, Special Controls

Product Code DDC Thyroglobulin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DDC Thyroglobulin, Antigen, Antiserum, Control

All 11
Devices cleared under the same product code (DDC) and FDA review panel - the closest regulatory comparables to K953066.
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QUANTA LITE(TM) THYROID T ELISA
K930486 · Inova Diagnostics, Inc. · Mar 1993
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · Miles Laboratories, Inc. · Feb 1987