The following data is part of a premarket notification filed by Digene Corp. with the FDA for Hybrid Capture System Cmv Dna Assay.
Device ID | K974901 |
510k Number | K974901 |
Device Name: | HYBRID CAPTURE SYSTEM CMV DNA ASSAY |
Classification | Antigen, Iha, Cytomegalovirus |
Applicant | DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
Contact | Constance A Finch |
Correspondent | Constance A Finch DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
Product Code | LJO |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-31 |
Decision Date | 1998-09-29 |
Summary: | summary |