510(k) Report

510(k) · Cleared

Cleared

Premier Coccidioides

K915493510(k) TraditionalCleared Jul 10, 1992214-day reviewClass II21 CFR 866.3135

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Meridian Diagnostics, Inc. · MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

Cleared on Jul 10, 1992 after a 214-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 10, 1992
Review
214 days
Class
Class II
Product code
MIY
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K915493Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MIY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MIY devices

MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIY

FDA has decided no MIY device since 2007.

Median 510(k) review, days · MIY

Too few MIY 510(k)s in any year since 2007 to give a median.

Recalls per year · MIY

No recall names MIY since 2007.

Adverse event reports per year · MIY

No MAUDE report names MIY since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Meridian Diagnostics, Inc.

92 FDA decisions under this applicant name. See the company

  • K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 19992 recalls
  • K990263Immunocard Stat! E. Coli O157:H7Meridian Diagnostics, Inc. · 1999
  • K984343Premier Type Specific HSV-1 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K984346Premier Type Specific HSV-2 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19981 recall

https://510kreport.com/device/K915493 · printed Nov 5, 2026

Cite this page

510(k) Report. “K915493: Premier Coccidioides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915493

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026