Data / Medical devices / United States / Pregmate LLC
Pregmate LLC: FDA-registered device maker in Hollywood, FL, United States, 16 510(k) clearances
Pregmate LLC is registered with the FDA (registration 3013679502) in Hollywood, FL, United States. It lists 27 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 5, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013679502
- Address
- 3804 N 29th Ave, Hollywood, FL, United States, 33020
- Owner or operator
- PREGMATE LLC (10055200)
- Roles
- Repackager or relabeler
- First device listed
- June 19, 2017
- Registered through
- 2026
- Brand names listed
- Checkmate 12 Panel Urine Drug Test Kit, Checkmate 6 Panel Urine Drug Test Kit, EZ Level At Home Urine Drug Test Kit, EZ Level Drug Screen Test Kit Dip Card, EZ Level Drug Test, EZ Level Instant Drug Test, EZ Level Instant Drug Test At Home Urine Drug Test Kit, EZ Level Multi-Drug Testing Kit and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 5, 2022 | K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | LCX | Substantially Equivalent | Co-Innovation Biotech Co., Ltd. | accessdata.fda.gov |
| August 13, 2020 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | LCX | Substantially Equivalent | Safecare Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| September 5, 2019 | K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent | Qingdao Hightop Biotech Co., Ltd. | accessdata.fda.gov |
| April 26, 2016 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | DJG | Substantially Equivalent | Co-Innovation Biotech Co., Ltd. | accessdata.fda.gov |
| March 18, 2016 | K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | DIO | Substantially Equivalent | Safecare Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| November 2, 2015 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | LDJ | Substantially Equivalent | Nantong Egens Biotech 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 |
| July 16, 2015 | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | DNK | Substantially Equivalent | Nantong Egens Biotech Co., Ltd. | accessdata.fda.gov |
| November 12, 2013 | K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | LCX | Substantially Equivalent | Co-Innovation Biotech Co., Ltd. | accessdata.fda.gov |
| March 14, 2013 | K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | LCX | Substantially Equivalent | Polymed Therapeutics, Inc. | accessdata.fda.gov |
| February 5, 2013 | K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | LCX | Substantially Equivalent | Nantong Biotechnology 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 |
| August 24, 2001 | K012252 | QUIK-CHECK OVULATION PREDICTOR | CEP | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 26, 2001 | K003987 | URS-1K (KETONE TESST) | JIN | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| October 28, 1998 | K981207 | CLEARPLAN EASY FERTILITY MONITOR | NGE | Substantially Equivalent | Unipath , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- All makers of Radioimmunoassay, Luteinizing Hormone
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
Updated April 5, 2022. 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.