IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT— 510(k) K870089

Name: FDA 510(k) clearance K870089
Creator: U.S. Food and Drug Administration
Published: 1987-03-17

Substantially Equivalent

Microscan Div. Baxter Healthcare Corp.

FDA 510(k) clearance K870089 for IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT, Substantially Equivalent on 1987-03-17. Applicant: Microscan Div. Baxter Healthcare Corp.. Device class: 2.

Clearance details

Applicant: Microscan Div. Baxter Healthcare Corp.
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1987-01-09
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTJ

view all

K952791 — DIRECTIGEN MENINGITIS COMBO TEST1996-05-30
K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT1992-03-23
K910210 — SLIDEX MENINGITE-KIT 51991-08-12
K885004 — BACTIGEN(R) N. MENINGITIDIS1989-02-07
K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL241986-02-04

More clearances from Microscan Div. Baxter Healthcare Corp.

view all

K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 21987-06-26
K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL1987-06-26
K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS1987-06-26
K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B1987-06-26
K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 31987-06-26

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