510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000316Substantially Equivalent

Meretek Ubt_lite Breath Test for H. Pylori

Meretek, Nashville TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K000316 is the FDA 510(k) clearance record for MERETEK UBT_LITE BREATH TEST FOR H. PYLORI, a class I device, cleared for Meretek on under FDA product code MSQ (Test, Urea (Breath Or Blood)). FDA records list one 510(k) clearance for Meretek. As of , FDA records show no recalls naming K000316.

Clearance record

Decision date
Received
(23 days to decision)
Product code
MSQ Test, Urea (Breath Or Blood)
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Meretek 618 Grassmere Park Dr., Nashville TN
510(k) summary
Summary
Third party review
No

Clearances, product code MSQ

Trailing 12 months

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

FDA records show no clearances under product code MSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSQ, 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