Cleared Traditional

K843207 - REPTILASE -PC

K843207 is an FDA 510(k) clearance for REPTILASE -PC, manufactured by Bio/Data Corp.. The device is a Class 2 Hematology device with product code JCO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K843207 · Bio/Data Corp. · Hematology device
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Oct 1984
Decision
69d
Days
Class 2
Risk

K843207 is an FDA 510(k) clearance for the REPTILASE -PC. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 69 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 Bio/Data Corp. devices

FDA 510(k) Submission Details - K843207

510(k) Number K843207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date October 23, 1984
Days to Decision 69 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
44d faster than avg
Panel avg: 113d · This submission: 69d
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 K843207.
BATROXOBIN REAGENT
K932787 · Behring Diagnostics, Inc. · Nov 1993
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-R HA35
K840210 · Wellcome Diagnostics · Apr 1984
ATROXIN
K780355 · Sigma Chemical Co. · Apr 1978