The following data is part of a premarket notification filed by Medscience Science Research Group, Inc. with the FDA for Allergiend St-9 Multiple Skin Test Applicator, Allergiend St-9 Multiple Well Test Tray.
| Device ID | K172062 |
| 510k Number | K172062 |
| Device Name: | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | MedScience Science Research Group, Inc. 16469 Bridlewood Circle Delray Beach, FL 33445 |
| Contact | Marvin Smollar |
| Correspondent | Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-07 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6821001360 | K172062 | 000 |
| B682ALK08H006 | K172062 | 000 |
| B682ALK10H006 | K172062 | 000 |
| B682ALK48T001 | K172062 | 000 |
| B682ALK8002 | K172062 | 000 |
| B68280021 | K172062 | 000 |
| B68210000 | K172062 | 000 |
| B6821000121 | K172062 | 000 |
| B682100040 | K172062 | 000 |
| B68210010 | K172062 | 000 |
| ALK80001 | K172062 | 000 |