The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Varicella-zoster Virus Ident..
| Device ID | K841526 |
| 510k Number | K841526 |
| Device Name: | ORTHO VARICELLA-ZOSTER VIRUS IDENT. |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-12 |
| Decision Date | 1984-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101212 | K841526 | 000 |