Cleared Traditional

K843215 - FACTOR IX DEFICIENT PLASMA, B9D -

K843215 is an FDA 510(k) clearance for FACTOR IX DEFICIENT PLASMA, manufactured by Sigma Chemical Co.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K843215 · Sigma Chemical Co. · Hematology device
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Nov 1984
Decision
96d
Days
Class 2
Risk

K843215 is an FDA 510(k) clearance for the FACTOR IX DEFICIENT PLASMA, B9D -. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K843215

510(k) Number K843215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date November 19, 1984
Days to Decision 96 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
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K843215.
ASSERA PLATE IX:AG KIT
K854014 · American Bioproducts Co. · Jan 1986
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · American Dade · Aug 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · American Dade · Aug 1985
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310 · Sigma Chemical Co. · Nov 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438 · Sigma Chemical Co. · Nov 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451 · Sigma Chemical Co. · Nov 1984