# K962423: Bblcrystal Neisseria/Haemophilus (N/H) System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Aug 2, 1996 after 39 days
- Product code: JST (Kit, Fastidious Organisms)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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 K881501 (1988). 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)
- K881501: Modified Ids Rapid NH System, Innovative Diagnostic Systems, Inc. (1988) Summary page 1.

## Indications for use
Use of this product is indicated when Neisseria, Haemophilus and the other fastidious organisms described in Table B-1 have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.

Source page: https://510kreport.com/device/K962423
Methodology: https://510kreport.com/methodology