Data / Medical devices / United States / Reese Pharmaceutical Company
Reese Pharmaceutical Company: FDA-registered device maker in Cleveland, OH, United States, 3 510(k) clearances
Reese Pharmaceutical Company is registered with the FDA (registration 1518939) in Cleveland, OH, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1518939
- Address
- 10617 Frank Ave, Cleveland, OH, United States, 44106
- Owner or operator
- Reese Pharmaceutical Company (9012606)
- Roles
- Repackager or relabeler
- First device listed
- December 16, 2009
- Registered through
- 2026
- Brand names listed
- Lice Combs, Reese's ColoTest, Super Wrap, URINARY TEST STRIP, Urinary Tract Infection Test Strips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Detectors And Removers, Lice, (Including Combs) | LJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | 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 |
|---|---|---|---|---|---|---|
| February 15, 2018 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 17, 2011 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | Substantially Equivalent | Teco Diagnostics | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Test, Urine Leukocyte
- All makers of Detectors And Removers, Lice, (Including Combs)
- All makers of Bandage, Elastic
- All makers of Reagent, Occult Blood
Updated February 15, 2018. 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.