# K034007: Hemosil Factor Viii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 13, 2004 after 51 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893525 (1989). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893525: Factor Viii Deficient Plasma, Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000) Summary page 1.

## Most influential descendants
- K110237: Hemosil Factor Viii Deficient Plasma (2011), 1 descendant of its own
- K222831: CRYOcheck Factor VIII Deficient Plasma with VWF (2023), 0 descendants of its own

## Indications for use
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.

Source page: https://510kreport.com/device/K034007
Methodology: https://510kreport.com/methodology