BOND MMR Antibody Panel
FDA 510(k) K213348 · Leica Biosystems Newcastle, Ltd.
510(k) numberK213348
Submission
- Device name
- BOND MMR Antibody Panel
- Applicant
- Leica Biosystems Newcastle, Ltd.
Newcastle Upon Tyne, GB - Received
- October 8, 2021
- Decision date
- February 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZJ – Lynch Syndrome Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1866
- Specialty
- Immunology
The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome
Other 510(k)s with product code PZJ
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Questions and answers
When was BOND MMR Antibody Panel cleared by the FDA?
BOND MMR Antibody Panel (K213348) received a 510(k) decision of Substantially Equivalent on February 21, 2023, 501 days after the submission was received.
What is the product code of K213348?
The FDA product code is PZJ – Lynch Syndrome Test System, a Class II (moderate risk) device regulated under 21 CFR 864.1866.