Cleared Traditional

K934584 - SPECTROLYSE FACTOR VII:C

K934584 is an FDA 510(k) clearance for SPECTROLYSE FACTOR VII:C, manufactured by Meditech, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K934584 · Meditech, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
74d
Days
Class 2
Risk

K934584 is an FDA 510(k) clearance for the SPECTROLYSE FACTOR VII:C. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Meditech, Inc. (Ventura, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 74 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 Meditech, Inc. devices

FDA 510(k) Submission Details - K934584

510(k) Number K934584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1993
Decision Date December 06, 1993
Days to Decision 74 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 113d · This submission: 74d
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 158
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K934584.
RISTOCETIN COFACTOR ASSAY KIT
K945414 · Chrono-Log Corp. · Jan 1995
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · Biomerieux Vitek, Inc. · Dec 1994
MDA PROTEIN ASSAY
K925617 · Organon Teknika Corp. · Jan 1994
NEW STACHROM PROTEIN C TEST KIT
K931906 · American Bioproducts Co. · Nov 1993
IL TEST(TM) PROTEIN S
K930327 · Instrumentation Laboratory CO · Apr 1993
IL TEST(TM) PRO-CHROM
K924884 · Instrumentation Laboratory CO · Jan 1993