XACT NEISSERIA— 510(k) K880511

Substantially Equivalent

Austin Biological Laboratories

FDA 510(k) clearance K880511 for XACT NEISSERIA, Substantially Equivalent on 1988-08-25. Applicant: Austin Biological Laboratories. Device class: 1.

Clearance details

Applicant: Austin Biological Laboratories
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-02-09
Decision date: 1988-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSX

K960759 — GONOPOX TEST KIT1996-09-18
K923566 — NIZYME TEST KIT1992-11-02
K913456 — VISI-NEISSERIA1991-10-11
K881501 — MODIFIED IDS RAPID NH SYSTEM1988-05-18
K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST1987-03-20

More clearances from Austin Biological Laboratories

K874727 — PRECEPT(TM) CIPROFLOXACIN1988-02-18
K870769 — AUSTIN NONFERMENTER KIT1987-04-03
K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID1986-11-13
K862446 — PRECEPT CEFTAZIDIME1986-07-11
K862560 — PRECEPT CEFTIZOXIME1986-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.