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

Vastervik, SE

GET TESTED INTERNATIONAL AB appears in FDA device records in Vastervik, SE. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 92 recalls for this company.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
92
Registered establishments
0

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

No FDA establishment registrations recorded against this company.

FDA product codes

No FDA product codes recorded against this company.

Recall records

Showing 25 of 92
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0818-20268 in 1 STI Test KitDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0817-20263 in 1 STI TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0816-20262 in 1 Trichomonas / Gardnerella TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0815-2026Serotonin TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0814-2026Pollen Allergy TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0813-2026Pet Allergy TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0812-2026Melatonin TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0811-2026Iron Deficiency Test (ferritin)Distribution without premarket approval/clearance.Class IIOpen, Classified
Z-0810-2026Iodine TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0809-2026Heavy Metals TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0808-2026Food Intolerance Test SmallDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0807-2026Food Intolerance Test MediumDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0806-2026Food Intolerance Test LargeDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0805-2026Estrogen & Progesterone TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0804-2026Allergy test SmallDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0803-2026Allergy test SmallDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0802-2026Allergy & Food Intolerance TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0801-2026Liver TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0800-2026Kidney TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0799-2026Diabetes Test (ketones & glucose)Distribution without premarket approval/clearance.Class IIOpen, Classified
Z-0798-2026Women s Hormone TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0797-2026Sorbitol Intolerance TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0796-2026SIBO TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0795-2026PSA TestDistribution without premarket approval/clearance.Class IIOpen, Classified
Z-0794-2026Peptic Ulcer Test (H, pylori)Distribution without premarket approval/clearance.Class IIOpen, Classified

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