The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Test Kit For Ena (rnp/sm) Antibodies.
| Device ID | K873708 |
| 510k Number | K873708 |
| Device Name: | FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Louise M Harris |
| Correspondent | Louise M Harris WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1987-11-25 |