The following data is part of a premarket notification filed by Biomedex, Inc. with the FDA for Dermapik Ii Skin Test System, Dermapik Ii (single Test Device), Polypik Ii (multiple Skin Test Device), Dermapik Tray, D.
| Device ID | K000299 |
| 510k Number | K000299 |
| Device Name: | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | BIOMEDEX, INC. 3380 MISTLETOE RD. Dallas, OR 97338 |
| Contact | James L Thompson |
| Correspondent | James L Thompson BIOMEDEX, INC. 3380 MISTLETOE RD. Dallas, OR 97338 |
| 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 | 2000-01-31 |
| Decision Date | 2000-04-28 |