Cleared Traditional

K954997 - CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT

K954997 is an FDA 510(k) clearance for CENTOCOR AGGRESTAT, manufactured by Centocor, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K954997 · Centocor, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
84d
Days
Class 2
Risk

K954997 is an FDA 510(k) clearance for the CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Centocor, Inc. (Malvern, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology 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 Centocor, Inc. devices

FDA 510(k) Submission Details - K954997

510(k) Number K954997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date January 24, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOZ Device Classification - Class 2, Special Controls

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 Hematology devices follow this clearance model.

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 30
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K954997.
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