Cleared Traditional

K934606 - STAGO FACTOR II-DEFICIENT PLASMA

K934606 is an FDA 510(k) clearance for STAGO FACTOR II-DEFICIENT PLASMA, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K934606 · American Bioproducts Co. · Hematology device
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Mar 1994
Decision
155d
Days
Class 2
Risk

K934606 is an FDA 510(k) clearance for the STAGO FACTOR II-DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 155 days - an extended review 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: 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K934606

510(k) Number K934606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date March 01, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJT Device Classification - Class 2, Special Controls

Product Code GJT Plasma, Coagulation Factor Deficient
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 - GJT Plasma, Coagulation Factor Deficient

All 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K934606.
FACTOR VII DEFICIENT PLASMA
K935056 · Sigma Diagnostics, Inc. · Mar 1994
FACTOR
K935058 · Sigma Diagnostics, Inc. · Mar 1994
STAGO FACTOR V-DEFICIENT PLASMA
K934605 · American Bioproducts Co. · Mar 1994
STAGO FACTOR IX-DEFICIENT PLASMA
K933432 · American Bioproducts Co. · Nov 1993
STAGO FACTOR XII-DEFICIENT PLASMA
K933438 · American Bioproducts Co. · Oct 1993
STAGO FACTOR VII-DEFICIENT PLASMA
K933440 · American Bioproducts Co. · Oct 1993