The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Ss-a (ro) Antibody Elisa, Immulisa Enhanced Ss-b (la) Antibody Elisa, Immulisa Enhanced Sm Antibody Elisa, Immulisa Enhanced Rnp Antibody Elisa.
| Device ID | K142781 |
| 510k Number | K142781 |
| Device Name: | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 9870 Hollingson Rd Clarence, NY 14031 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 9870 Hollingson Rd Clarence, NY 14031 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-03-31 |