Bartels Chemoresponse Assay
PMA P940036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP940036 | Date1 Aug 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Test, anti-tumor cell susceptibility
- PMA Number
- FDA Product Code
- MHR
- Device Class
- Class III
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Bartels Chemoresponse Assay is a test for anti-tumor cell susceptibility, as defined by its generic name and device classification. It is designed to evaluate the response of tumor cells to chemotherapeutic agents.
Manufactured by Bartels Prognostics, Inc., the assay was granted FDA PMA approval (P940036) on August 1, 1996, following an expedited review. It is classified under product code MHR and was submitted from the company’s address in Issaquah, WA. The device is intended for use in laboratory settings as part of microbiological analysis, with no indication of sterility, single-use status, or MRI safety provided in the data.
Questions
AI-generated answers, 18 Sep 2026
What is the Bartels Chemoresponse Assay used for?
The Bartels Chemoresponse Assay is a test for anti-tumor cell susceptibility, meaning it evaluates how tumor cells respond to chemotherapy drugs. This information is derived from its generic name and device classification in the provided data.
Who manufactures the Bartels Chemoresponse Assay and when was it approved?
The Bartels Chemoresponse Assay is manufactured by Bartels Prognostics, Inc. It received FDA PMA approval on August 1, 1996, under application number P940036, following an expedited review process.
What regulatory pathway was used for the Bartels Chemoresponse Assay?
The Bartels Chemoresponse Assay was approved via the FDA Premarket Approval (PMA) pathway, as indicated by the AUTHORIZATIONS field listing FDA_PMA and the PMA number P940036 in the specifications.