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

Phoenix, AZ, US

Caris MPI, Inc appears in FDA device records in Phoenix, AZ. FDA records list no 510(k) clearances, 8 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
8
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Caris MPI, 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.

  • Caris Life SciencesPMA, 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 Caris MPI, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30170201413008335090Caris MPI, Inc4610 S 44th Pl, Phoenix, AZ 85040 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-2521-2025MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.Due to an incorrect test results provided that indicated the incorrect drug therapy recommendationClass IIOpen, Classified

Verification record

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