KULTSURE— 510(k) K871404

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K871404 for KULTSURE, Substantially Equivalent on 1987-04-21. 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: 1987-04-08
Decision date: 1987-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, L4z 1y6, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Ncs Diagnostics, Inc.

K943498 — KULTSURE STARSWAB (M210), MODIFICATION1994-11-30
K943499 — KULTSURE STARSWAB(M240), MODIFICATION1994-11-30
K882811 — STREPSLIDE1988-10-25
K881209 — ASO SLIDE TEST1988-04-12
K874019 — STAPHSLIDE1987-10-28

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