510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Inverness Medical-Biostar, Inc.

Louisville, CO, US

Inverness Medical-Biostar, Inc. appears in FDA device records in Louisville, CO. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
0

FDA records under these names

1 name

FDA records resolved to Inverness Medical-Biostar, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Thermo Biostar, Incorporatedrecall

510(k) clearance history

FDA records hold 1 510(k) clearance for Inverness Medical-Biostar, Inc. in 2006.

Clearances by year, as a table
510(k) clearance decisions for Inverness Medical-Biostar, Inc., by decision year
YearClearances
20061
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K061889BIOSTAR OIA SHIGATOXGMZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0212-2009BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027Diagnostic kits for flu were distributed with incorrect components.Terminated
Z-0616-03Chlamydia OIA. For in vitro diagnostic use.Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.Terminated
Z-0615-03Chlamydia OIA. For in vitro diagnostic use,Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain