The following data is part of a premarket notification filed by Hmb Medical Concepts, Ltd. with the FDA for Allersharp Allergy Skin Tester.
| Device ID | K011979 |
| 510k Number | K011979 |
| Device Name: | ALLERSHARP ALLERGY SKIN TESTER |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | HMB MEDICAL CONCEPTS, LTD. 1695 RIDGE HAVEN RUN Alpharetta, GA 30022 |
| Contact | Gavin Mclachlan |
| Correspondent | Gavin Mclachlan HMB MEDICAL CONCEPTS, LTD. 1695 RIDGE HAVEN RUN Alpharetta, GA 30022 |
| 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 | 2001-06-25 |
| Decision Date | 2001-09-14 |