# K993825: Para Tech Plus Retics

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Nov 30, 1999 after 18 days
- Product code: JCN (Control, Cell Counter, Normal And Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896154 (1989). 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)
- K896154: Para Tech for Technicon H-1, Streck Laboratories, Inc. (1989) Summary page 1.

## Most influential descendants
- K041240: Semen Analysis Quality Control, Assayed and Unassayed (2004), 0 descendants of its own

## Recalls of this device
- Jun 4, 2025 · Class II · Z-2088-2025: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Jun 4, 2025 · Class II · Z-2087-2025: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Jun 4, 2025 · Class II · Z-2089-2025: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

## Indications for use
Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.

Source page: https://510kreport.com/device/K993825
Methodology: https://510kreport.com/methodology