PREMIER-CRYPTOCOCCAL ANTIGEN— 510(k) K904393

Name: FDA 510(k) clearance K904393
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K904393 for PREMIER-CRYPTOCOCCAL ANTIGEN, Substantially Equivalent on 1991-01-25. Applicant: Meridian Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code MDU
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1990-09-25
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA2012-12-17

More clearances from Meridian Diagnostics, Inc.

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K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
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K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST1999-06-25
K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

Recalls naming K904393

K-number listed on FDA's recall record

Z-0732-2019 — PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).Class II·Terminated·Meridian Bioscience Inc·20181217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904393.

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