Cleared Traditional

K841523 - OWREN'S VERONAL BUFFERR

K841523 is an FDA 510(k) clearance for OWREN'S VERONAL BUFFERR, manufactured by Diatech, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841523 · Diatech, Inc. · Hematology device
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Jun 1984
Decision
50d
Days
Class 2
Risk

K841523 is an FDA 510(k) clearance for the OWREN'S VERONAL BUFFERR. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Diatech, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 50 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 Diatech, Inc. devices

FDA 510(k) Submission Details - K841523

510(k) Number K841523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1984
Decision Date June 01, 1984
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K841523.
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · Warner-Lambert Co. · May 1985
COBAS-FIBRO
K842717 · Roche Diagnostic Systems, Inc. · Oct 1984
HEPARIN COAGULATION CONTROL PLASMA 1-
K841462 · Diatech, Inc. · Jun 1984
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983
DIGICLOT 2-#820
K812121 · Volu Sol Medical Industries · Nov 1981