The following data is part of a premarket notification filed by Aller/guard, Inc. with the FDA for Hmb Allergogen Skin Prick Test Needle.
| Device ID | K844221 |
| 510k Number | K844221 |
| Device Name: | HMB ALLERGOGEN SKIN PRICK TEST NEEDLE |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | ALLER/GUARD, INC. P.O. BOX 58027 Topeka, KS 66658 |
| Contact | James H Ransom |
| Correspondent | James H Ransom ALLER/GUARD, INC. P.O. BOX 58027 Topeka, KS 66658 |
| 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 | 1984-11-01 |
| Decision Date | 1985-02-08 |