510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Exact Sciences Corporation- Innovation Campus

Madison, WI, US

Exact Sciences Corporation- Innovation Campus appears in FDA device records in Madison, WI. FDA records list no 510(k) clearances, 83 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
83
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Exact Sciences Corporation- Innovation Campus 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.

  • Exact Sciences CorporationPMA, enforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Exact Sciences Corporation- Innovation Campus, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30082561183008256118Exact Sciences Corporation- Innovation Campus441 Charmany Dr, Madison, WI 53719 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2219-2017Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic testsExact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.Class IITerminated

Verification record

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