Data / Medical devices / United States / Sci Medic, Inc.
Sci Medic, Inc.: FDA-registered device maker in Frederick, MD, United States, 8 510(k) clearances
Sci Medic, Inc. is registered with the FDA (registration 3003791481) in Frederick, MD, United States. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003791481
- Address
- 7311 Grove Road Unit L, Frederick, MD, United States, 21704
- Owner or operator
- SCI MEDIC, INC. (9056701)
- Roles
- Repackager or relabeler
- First device listed
- April 8, 2005
- Registered through
- 2026
- Brand names listed
- NEW CHOICE, NEW CHOICE PLUS, U-CHECK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Liquid Chromatography, Morphine | DPK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2025 | K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | Assure Tech., LLC | accessdata.fda.gov |
| June 21, 2024 | K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. | accessdata.fda.gov |
| August 7, 2015 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 8, 2005 | K043443 | ONE STEP HCG URINE PREGNANCY TEST | LCX | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| July 10, 2000 | K994409 | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST | DPK | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| June 21, 2000 | K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST | LDJ | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | LCX | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Enzyme Immunoassay, Cannabinoids
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Test, Urine Leukocyte
Updated January 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.