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

Huntersville, NC, US

UNISTRIP TECHNOLOGIES, LLC appears in FDA device records in Huntersville, NC. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Unistrip Technologies LLC in 2013.

Clearances by year, as a table
510(k) clearance decisions for Unistrip Technologies LLC, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K113135UNISTRIP 1NBWSubstantially Equivalent

Registered establishments

FDA registered establishments for Unistrip Technologies LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30106221843010622184UNISTRIP TECHNOLOGIES, LLC11621 Patterson Road, Huntersville, NC 28078 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0855-2015UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.Failure to submit a 510(k) for device labeling changes.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain