510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964151Substantially Equivalent

Bard and Bta Test

Bard Diagnostic Sciences,Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964151 is the FDA 510(k) clearance record for BARD AND BTA TEST, a class II device, cleared for Bard Diagnostic Sciences,Inc. on under FDA product code MMW (System, Test, Tumor Marker, Monitoring, Bladder). FDA records list 3 510(k) clearances for Bard Diagnostic Sciences,Inc., from to . As of , FDA records show no recalls naming K964151.

Clearance record

Decision date
Received
(197 days to decision)
Product code
MMW System, Test, Tumor Marker, Monitoring, Bladder
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Bard Diagnostic Sciences,Inc. 12277 134th Ct., NE, #100, Redmond WA
510(k) summary
Summary
Third party review
No

Clearances, product code MMW

Trailing 12 months

FDA records hold no clearances under product code MMW in the trailing twelve months.

FDA records show no clearances under product code MMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260