Data / Medical devices / United States / Medscience Research Group, Inc.
Medscience Research Group, Inc.: FDA-registered device maker in West Palm Beach, FL, United States, 1 510(k) clearance
Medscience Research Group, Inc. is registered with the FDA (registration 3010131789) in West Palm Beach, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010131789
- Address
- 1118 25th Street #6, West Palm Beach, FL, United States, 33407
- Owner or operator
- Medscience Research Group, Inc. (10058191)
- Roles
- Specification developer
- First device listed
- July 25, 2018
- Registered through
- 2026
- Brand names listed
- AllerTest Multiple Well Test Tray, AllerTest Skin Test Applicator, ST Single Head Skin Test Applicator, ST-9 Multiple Well Test Tray, ST-9 Skin Test Applicator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Allergen And Vaccine Delivery Needles | SCL | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 5, 2018 | K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | SCL | Substantially Equivalent | Medscience Science Research Group, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 22, 2016 | 73664 | Class II | Terminated | AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify react | During an FDA inspection it was found that the products are marketed without a cleared 510k. | accessdata.fda.gov |
Compare with other makers
Updated March 5, 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.