Cleared Traditional

K896033 - FDP COLLECTION TUBES

K896033 is the FDA 510(k) clearance for FDP COLLECTION TUBES by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code JCO) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K896033 · Medical Diagnostic Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
11d
Days
Class 2
Risk

K896033 is an FDA 510(k) clearance for the FDP COLLECTION TUBES. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8100 - 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K896033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date October 27, 1989
Days to Decision 11 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
102d faster than avg
Panel avg: 113d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCO Bothrops Atrox Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8100
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 - JCO Bothrops Atrox Reagent

Devices cleared under the same product code (JCO) and FDA review panel - the closest regulatory comparables to K896033.
VENOM TIEM REAGENT
K955115 · Medical Diagnostic Technologies, Inc. · Apr 1996
BATROXOBIN REAGENT
K932787 · Behring Diagnostics, Inc. · Nov 1993
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
K852519 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
REPTILASE -PC
K843207 · Bio/Data Corp. · Oct 1984
ATROXIN
K780355 · Sigma Chemical Co. · Apr 1978