IMMUNOCARD STAT! ROTAVIRUS— 510(k) K971585

Name: FDA 510(k) clearance K971585
Creator: U.S. Food and Drug Administration
Published: 1997-08-20

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K971585 for IMMUNOCARD STAT! ROTAVIRUS, Substantially Equivalent on 1997-08-20. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1997-05-01
Decision date: 1997-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIQ

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K990842 — SAS ROTA TEST1999-08-09
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05
K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT1996-02-14

More clearances from Meridian Diagnostics, Inc.

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K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
K990263 — IMMUNOCARD STAT! E. COLI O157:H71999-08-09
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 K971585

K-number listed on FDA's recall record

Z-0678-2022 — meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.Class II·Terminated·MEDLINE INDUSTRIES, LP - Northfield·20220125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971585.

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