The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Resp. Panel 1 Indirect Immunofluorescence Assay.
| Device ID | K922801 |
| 510k Number | K922801 |
| Device Name: | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Antisera, Fluorescent, Adenovirus 1-33 |
| Applicant | LIGHT DIAGNOSTICS 27520 ENTERPRISE CIRCLE WEST Temecula, CA 92390 |
| Contact | Dale Dembrow |
| Correspondent | Dale Dembrow LIGHT DIAGNOSTICS 27520 ENTERPRISE CIRCLE WEST Temecula, CA 92390 |
| Product Code | GNY |
| CFR Regulation Number | 866.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-10 |
| Decision Date | 1993-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436037122651 | K922801 | 000 |
| 08436037123078 | K922801 | 000 |
| 04053252789168 | K922801 | 000 |
| 04053252284311 | K922801 | 000 |
| 04053252286575 | K922801 | 000 |