Cleared Traditional

K883484 - OWREN'S VERONAL BUFFER

K883484 is the FDA 510(k) clearance for OWREN'S VERONAL BUFFER by Helena Laboratories. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K883484 · Helena Laboratories · Hematology device
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Aug 1988
Decision
9d
Days
Class 2
Risk

K883484 is an FDA 510(k) clearance for the OWREN'S VERONAL BUFFER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 25, 1988 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Helena Laboratories devices

Submission Details

510(k) Number K883484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date August 25, 1988
Days to Decision 9 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
104d faster than avg
Panel avg: 113d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K883484.
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · King Diagnostics, Inc. · Oct 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · King Diagnostics, Inc. · Oct 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · King Diagnostics, Inc. · Oct 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · Instrumentation Laboratory CO · Jun 1988
CHROM-TROL
K872377 · Helena Laboratories · Jul 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · International Technidyne Corp. · Jun 1987