NEISSERIA - KWIK PLUS— 510(k) K852998

Substantially Equivalent

Micro-Bio-Logics

FDA 510(k) clearance K852998 for NEISSERIA - KWIK PLUS, Substantially Equivalent on 1985-07-23. Applicant: Micro-Bio-Logics. Device class: 1.

Clearance details

Applicant: Micro-Bio-Logics
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1985-07-15
Decision date: 1985-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, 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
K880511 — XACT NEISSERIA1988-08-25
K881501 — MODIFIED IDS RAPID NH SYSTEM1988-05-18

More clearances from Micro-Bio-Logics

K870731 — LYFO KWIK(TM) RUS KIT1987-06-17
K861312 — LYFO-KWIK (TM) COAGULASE PLASMA1986-04-18
K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS1986-04-04
K855172 — KWI (TM) G-CO/TWO1986-02-20
K855198 — INDI KWIK (TM) CO/TWO KIT1986-01-14

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