KULTSURE STARSWAB(M240), MODIFICATION— 510(k) K943499

Name: FDA 510(k) clearance K943499
Creator: U.S. Food and Drug Administration
Published: 1994-11-30

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K943499 for KULTSURE STARSWAB(M240), MODIFICATION, Substantially Equivalent on 1994-11-30. Applicant: Ncs Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ncs Diagnostics, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1994-06-13
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Etobicoke, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSM

view all

K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device2025-11-26
K250205 — Babio® Virus Transport Kit (Non-inactivating)2025-09-22
K242576 — AllTest Viral Transport Medium2025-04-04
K232565 — UriSponge2024-10-11
K220908 — Ensol EnTM Specimen Collection and Transport System2024-08-29

More clearances from Ncs Diagnostics, Inc.

view all

K943498 — KULTSURE STARSWAB (M210), MODIFICATION1994-11-30
K882811 — STREPSLIDE1988-10-25
K881209 — ASO SLIDE TEST1988-04-12
K874019 — STAPHSLIDE1987-10-28
K871404 — KULTSURE1987-04-21

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