# K983475: Hemochron Response

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: May 3, 1999 after 213 days
- Product code: KQG (Instrument, Coagulation)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930068 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930068: Hemochron Model 8000/Factor VI Premier Coagulation, Technidyne Corp. (1993) Summary page 2.
- (no number) HEMOCHRON® Model 401: named in the summary without a submission number
- (no number) HEMOCHRON® Model 801: named in the summary without a submission number

## Most influential descendants
- K030818: Hemochron Response/System (2003), 0 descendants of its own

## Recalls of this device
- Nov 30, 2010 · Not classified · Z-1093-2011: Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.

## Indications for use
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays Activated Clotting Time (ACT) — All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) — All HEMOCHRON types Prothrombin Time (PT) — All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types For In Vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K983475
Methodology: https://510kreport.com/methodology