Cleared Traditional

K843310 - FACTOR X DEFICIENT PLASMA

K843310 is the FDA 510(k) clearance for FACTOR X DEFICIENT PLASMA by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K843310 · Sigma Chemical Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
88d
Days
Class 2
Risk

K843310 is an FDA 510(k) clearance for the FACTOR X DEFICIENT PLASMA, BLOD HUMAN. 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 88 days - a notably fast clearance cycle.

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: 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K843310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1984
Decision Date November 19, 1984
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K843310.
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
K853461 · American Dade · Aug 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
K853462 · American Dade · Aug 1985
FACTOR IX DEFICIENT PLASMA, B9D -
K843215 · 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
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
K842617 · American Dade · Oct 1984