The following data is part of a premarket notification filed by Panatrex, Inc. with the FDA for Quanti-test System.
| Device ID | K982578 |
| 510k Number | K982578 |
| Device Name: | QUANTI-TEST SYSTEM |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | PANATREX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PANATREX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| 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 | 1998-07-23 |
| Decision Date | 1998-09-02 |