Cleared Traditional

K932787 - BATROXOBIN REAGENT

K932787 is an FDA 510(k) clearance for BATROXOBIN REAGENT, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JCO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K932787 · Behring Diagnostics, Inc. · Hematology device
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Nov 1993
Decision
173d
Days
Class 2
Risk

K932787 is an FDA 510(k) clearance for the BATROXOBIN REAGENT. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on November 29, 1993 after a review of 173 days - an extended review 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: 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K932787

510(k) Number K932787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date November 29, 1993
Days to Decision 173 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
60d slower than avg
Panel avg: 113d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCO Device Classification - Class 2, Special Controls

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 K932787.
VENOM TIEM REAGENT
K955115 · Medical Diagnostic Technologies, Inc. · Apr 1996
FDP COLLECTION TUBES
K896033 · Medical Diagnostic Technologies, Inc. · Oct 1989
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
REPTILASE-R HA35
K840210 · Wellcome Diagnostics · Apr 1984
ATROXIN
K780355 · Sigma Chemical Co. · Apr 1978