The following data is part of a premarket notification filed by Light Diagnostics with the FDA for Cytomegalovirus Direct Immunofluorescence Assay.
| Device ID | K951821 |
| 510k Number | K951821 |
| Device Name: | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Contact | Dale Dembrow |
| Correspondent | Dale Dembrow LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. Temecula, CA 92590 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1996-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053252368745 | K951821 | 000 |
| 04053252282089 | K951821 | 000 |
| 04053252507397 | K951821 | 000 |