510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180014Unknown

WOUNDCHEK Bacterial Status

Alere Scarborough, Inc., Scarborough ME / Direct, Unknown
FDA source (opens on fda.gov)

DEN180014 is the FDA 510(k) clearance record for WOUNDCHEK Bacterial Status, a class II device, cleared for Alere Scarborough, Inc. on under FDA product code QFA (Assay For Detection Of Proteases In Chronic Wounds). FDA's definition for product code QFA reads: "A device to detect bacterial protease activity in chronic wound fluid is a lateral flow prescription device that may include a sterile swab. The device is intended for use in patients as an aid in assessing the risk for non-healing of...". FDA records list 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show no recalls naming DEN180014.

Clearance record

Decision date
Received
(619 days to decision)
Product code
QFA Assay For Detection Of Proteases In Chronic Wounds
Regulation
21 CFR 866.3231
Device class
Class II
Review panel
Microbiology
Applicant
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
Third party review
No

Clearances, product code QFA

Trailing 12 months

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

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