FDA.report

510(k) K231221

Device
MDx-Chex for BC-GP
Applicant
Streck
510(k) number
K231221
Product code
PMN
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-27
Date received
2023-04-28
Regulation
866.3920
Classification name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Megan Hiveley
Address
7002 S 109th St. La Vista NE US 68128 68128

FDA Registration Numbers

Source Documents

510(k) summary PDF

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