The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Aurolite 1b.
| Device ID | K940343 |
| 510k Number | K940343 |
| Device Name: | AUROLITE 1B |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
| Contact | Dr. Manoharlal Malhotra |
| Correspondent | Dr. Manoharlal Malhotra ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-03-04 |