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Oak Tree International Holdings, Inc.

Las Vegas, NV, US

OAK TREE INTERNATIONAL HOLDINGS, INC. appears in FDA device records in Las Vegas, NV. FDA records list no 510(k) clearances, 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
0
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Oak Tree International Holdings, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30065398903006539890OAK TREE INTERNATIONAL HOLDINGS, INC.9550 S Eastern Ave Ste 253, Las Vegas, NV 89123 US2026No device listings on this registration

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

FDA product codes

No FDA product codes recorded against this company.

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1937-2009EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.Terminated

Verification record

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