Company
Universal Meditech Inc.
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)
28recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 7 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 5 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 2 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 2 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | 1 |
| ORA | Breast Milk-Alcohol Test System | 1 |
| QKO | Reagent, Coronavirus Serological | 1 |
| QKP | Coronavirus Antigen Detection Test System. | 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) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS Ovulation Predictor Midstream REF 200-17 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS Pregnancy Test Midstream REF 100-17 Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Open, Classified |
JHI | K963133 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Open, Classified |
JHI | K050741 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. Lem Fertility LH Ovulation Test (Strip) REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. Lem Fertility hCG Pregnancy Urine Test REF 100-12 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 Open, Classified |
CGJ | K052662 |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Open, Classified |
QKO | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Open, Classified |
JMT | K993850 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Open, Classified |
JIN | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Open, Classified |
LCX | K110889 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips Open, Classified |
NGE | K110889 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS Open, Classified |
ORA | None listed |
| Oct 23, 2023 | Universal Meditech Inc. To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Open, Classified |
JHI | K963132 |
| Oct 23, 2023 | Universal Meditech Inc. Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Open, Classified |
LCX | K974059 |
| Oct 23, 2023 | Universal Meditech Inc. DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Open, Classified |
JHI | K050741 |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Open, Classified |
CEN | None listed |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Open, Classified |
JIN | None listed |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser UriTest" UTI Test Strips REF 900-UTI Open, Classified |
NGJ | K103037 |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Open, Classified |
JMT | K993850 |
| Oct 23, 2023 | Universal Meditech Inc. One Step Ovulation Test REF 200-01 Open, Classified |
NGE | None listed |
| Oct 23, 2023 | Universal Meditech Inc. One Step Pregnancy Test REF 100-01 Open, Classified |
LCX | K110889 |
| Jan 27, 2023 | Universal Meditech Inc. Products are labeled as:
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT
Green and white box under the brand DiagnosUS,
and,
White box without brand name Open, Classified |
QKP | None listed |