CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530— 510(k) K854666
Substantially EquivalentClinical Sciences, Inc.
FDA 510(k) clearance K854666 for CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530, Substantially Equivalent on 1986-02-05. Applicant: Clinical Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Sciences, Inc.
- Product code
- Product code GQI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whippany, NJ, US
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