The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Advantage Chemiluminescence Prostate Specific Antigen (psa) Immunoassay.
| Device ID | K980716 |
| 510k Number | K980716 |
| Device Name: | ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Dave Smith |
| Correspondent | Dave Smith NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-07 |
| Decision Date | 1998-04-03 |
| Summary: | summary |