The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Cytomegelisa M Test Kit.
| Device ID | K854839 |
| 510k Number | K854839 |
| Device Name: | CYTOMEGELISA M TEST KIT |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader 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 | 1985-12-04 |
| Decision Date | 1986-02-04 |