510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190613Substantially Equivalent

BD MAX Check-Points CPO

Check-Points Health B.V., Wageningen, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190613 is the FDA 510(k) clearance record for BD MAX Check-Points CPO, a class II device, cleared for Check-Points Health B.V. on under FDA product code POC (System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen). FDA's definition for product code POC reads: "To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology". FDA records list one 510(k) clearance for Check-Points Health B.V. As of , FDA records show no recalls naming K190613.

Clearance record

Decision date
Received
(171 days to decision)
Product code
POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Check-Points Health B.V. Binnenhaven 5, Wageningen, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POC

Trailing 12 months
1 clearance under product code POC in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260