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 |