The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax(r) Test Kit Cytomegalovirus M Antibodies.
| Device ID | K863798 |
| 510k Number | K863798 |
| Device Name: | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Louise Harris |
| Correspondent | Louise Harris WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | LKQ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-29 |
| Decision Date | 1987-04-14 |