Reference Source

Labsystems Oy (Farmos Diag.) · 89-08 · FINLAND

For Labsystems Oy (Farmos Diag.), import alert is 89-08; country is FINLAND; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 89 - - - -- Physical Medicine; date published is 09/16/2009; address is Pulttitie 8 , Helsinki, Uusimaa FINLAND, verified against its source on 2026-09-30.

Firm
Labsystems Oy (Farmos Diag.) verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
FINLAND verified
Address
Pulttitie 8 , Helsinki, Uusimaa FINLAND verified
Date published
09/16/2009 verified
Product code
89 - - - -- Physical Medicine verified
FDA notes
Tetanus IgG EIA Kit verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Labsystems Oy (Farmos Diag.) Date Published : 09/16/2009 Pulttitie 8 , Helsinki, Uusimaa FINLAND

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and FDA notes

89 - - - -- Physical Medicine Date Published: 09/16/2009 Notes: Tetanus IgG EIA Kit

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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