The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Elisa Rubella Igm.
Device ID | K914420 |
510k Number | K914420 |
Device Name: | ELISA RUBELLA IGM |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | Martin King |
Correspondent | Martin King SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-03 |
Decision Date | 1991-12-27 |