Cleared Traditional

K881999 - PLATELIN EXCEL L

K881999 is an FDA 510(k) clearance for PLATELIN EXCEL L, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code GIT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K881999 · Organon Teknika Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
97d
Days
Class 2
Risk

K881999 is an FDA 510(k) clearance for the PLATELIN(R) EXCEL L. Classified as Reagent & Control, Partial Thromboplastin Time (product code GIT), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 17, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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: 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K881999

510(k) Number K881999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date August 17, 1988
Days to Decision 97 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
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIT Device Classification - Class 2, Special Controls

Product Code GIT Reagent & Control, Partial Thromboplastin Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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.