Cleared Traditional

K850409 - GEN. DIAG. CHROMOSTRATE REF. PLASMA

K850409 is the FDA 510(k) clearance for GEN. DIAG. CHROMOSTRATE REF. PLASMA by Warner-Lambert Co.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K850409 · Warner-Lambert Co. · Hematology device
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May 1985
Decision
93d
Days
Class 2
Risk

K850409 is an FDA 510(k) clearance for the GEN. DIAG. CHROMOSTRATE REF. PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on May 8, 1985 after a review of 93 days - within the typical 510(k) review window.

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: 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K850409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date May 08, 1985
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
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 K850409.
CITREX II
K853077 · Bio/Data Corp. · Aug 1985
CITREX III
K853078 · Bio/Data Corp. · Aug 1985
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
K851127 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
COBAS-FIBRO
K842717 · Roche Diagnostic Systems, Inc. · Oct 1984
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983