# K964409: HCL - 200 Biochemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Hcl Laboratory Systems, Inc.
- Decided: Jan 22, 1997 after 79 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- 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 K851172 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851172: Cobas Mira, Roche Diagnostic Systems, Inc. (1985) Summary page 1.

## Indications for use
The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.

Source page: https://510kreport.com/device/K964409
Methodology: https://510kreport.com/methodology