The following data is part of a premarket notification filed by David A. Fuccillo, Ph.d. with the FDA for Ro Eia Test Kit.
| Device ID | K935416 |
| 510k Number | K935416 |
| Device Name: | RO EIA TEST KIT |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | DAVID A. FUCCILLO, PH.D. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader DAVID A. FUCCILLO, PH.D. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-09 |
| Decision Date | 1994-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743747 | K935416 | 000 |