# K962558: Chlamydia Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Feb 24, 1997 after 238 days
- Product code: LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group))
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chlamydia IFA: named in the summary without a submission number

## Indications for use
The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.

Source page: https://510kreport.com/device/K962558
Methodology: https://510kreport.com/methodology