DeviceClearance

ADVIA Centaur Herpes-2 IgG— 510(k) K181334

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K181334 for ADVIA Centaur Herpes-2 IgG, Substantially Equivalent on 2018-08-23. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant
Biokit, S.A.
Product code
Code MYF
Device class
Class 2
Regulation
21 CFR 866.3305
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lliça D'Amunt, ES
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MYF

product code MYF
Injury
316
Other
1
Total
317

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K181334

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181334.

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