The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Seriological Test Kit/igm Antibody Vari-zost Virus.
| Device ID | K914022 |
| 510k Number | K914022 |
| Device Name: | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Judith Smith |
| Correspondent | Judith Smith PHARMACIA DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-09 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743532 | K914022 | 000 |
| 05391516746830 | K914022 | 000 |
| 05391516746793 | K914022 | 000 |
| 05391516746755 | K914022 | 000 |