Company
GET TESTED INTERNATIONAL AB
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
92recalls (92 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 11 |
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 6 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 5 |
| CKG | Radioimmunoassay, Acth | 3 |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 3 |
| NRH | System, Breath Measurement | 3 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 3 |
| QWZ | Prognostic Test For Assessment Of Chronic Kidney Disease Progression | 3 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 2 |
| LMG | Agent, Absorbable Hemostatic, Non-Collagen Based | 2 |
| LYR | Helicobacter Pylori | 2 |
| MRG | System, Test, Vitamin D | 2 |
| NXO | Calprotectin, Fecal | 2 |
| POV | Semen Analysis Device | 2 |
| CDA | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHM | Radioimmunoassay, Total Estrogens In Pregnancy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Open, Classified |
OUY | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 3 in 1 STI Test Open, Classified |
OUY | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 2 in 1 Trichomonas / Gardnerella Test Open, Classified |
OUY | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Serotonin Test Open, Classified |
CDA | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Pollen Allergy Test Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Pet Allergy Test Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Melatonin Test Open, Classified |
LMG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Iron Deficiency Test (ferritin) Open, Classified |
LMG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Iodine Test Open, Classified |
JIJ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Heavy Metals Test Open, Classified |
JMG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Small Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Medium Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Food Intolerance Test Large Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Estrogen & Progesterone Test Open, Classified |
CHM | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy test Small Open, Classified |
NHG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy test Small Open, Classified |
DHB | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy & Food Intolerance Test Open, Classified |
QWZ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Liver Test Open, Classified |
QWZ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Kidney Test Open, Classified |
QWZ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Diabetes Test (ketones & glucose) Open, Classified |
JIL | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Women s Hormone Test Open, Classified |
NHG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sorbitol Intolerance Test Open, Classified |
NRH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB SIBO Test Open, Classified |
NRH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB PSA Test Open, Classified |
LTJ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Peptic Ulcer Test (H, pylori) Open, Classified |
LYR | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Parasite Test Open, Classified |
PCH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Organic acids Test Open, Classified |
LPT | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Neurotransmitters XL Open, Classified |
CKG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Neurotransmitters Plus Open, Classified |
CKG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Neurotransmitters Basic Open, Classified |
CKG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Men s Hormone Test Open, Classified |
CDZ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Leaky Gut Test Open, Classified |
NXO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Lactose Intolerance Test Open, Classified |
NRH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Intestinal Worms Test Open, Classified |
PCH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB IBS Test Open, Classified |
NXO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Hair Mineral Analysis Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Gut Microbiome Test XL Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Gut Microbiome Test Small Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Gut Microbiome Test Mega Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Gut Microbiome Test Medium Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Gut Microbiome Test Large Open, Classified |
QPO | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Fructose Intolerance Test Open, Classified |
JKC | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB DHEA Test Open, Classified |
JKC | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Candida Test Open, Classified |
LRF | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Biological Age & Longevity Test Open, Classified |
QDR | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Akkermansia Test Open, Classified |
PPM | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Adrenal Test Open, Classified |
NHG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Cholesterol Test Open, Classified |
NAQ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Continuous Glucose Monitor (CGM) Open, Classified |
QBJ | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Allergy Test IgE Open, Classified |
DHB | None listed |
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