ALBICANS SURE— 510(k) K913426

Substantially Equivalent

Jrga Diagnostics

FDA 510(k) clearance K913426 for ALBICANS SURE, Substantially Equivalent on 1992-04-22. Applicant: Jrga Diagnostics. Device class: 1.

Clearance details

Applicant: Jrga Diagnostics
Product code: Code JXC
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-08-01
Decision date: 1992-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Recent devices under product code JXC

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K884720 — GERM TUBE SOLUTION1989-06-02
K891476 — C. ALBICANS SCREEN1989-04-12
K882371 — SOC SLIDE CULTURE SYSTEM1988-07-18
K832406 — QUANTUM II YEAST IDENT. SYSTEM1983-09-26

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