VISUWELL(R) CHLAMYDIA— 510(k) K900973

Substantially Equivalent

Adi Diagnostics, Inc.

FDA 510(k) clearance K900973 for VISUWELL(R) CHLAMYDIA, Substantially Equivalent on 1990-05-15. Applicant: Adi Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Adi Diagnostics, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1990-03-02
Decision date: 1990-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rexdale, Ontario, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Adi Diagnostics, Inc.

K910487 — VISUWELL SYPHILIS ANTIGEN1991-06-24
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K890840 — VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT1989-03-27

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