CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY— 510(k) K894002
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K894002 for CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY, Substantially Equivalent on 1989-08-10. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code LIN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
Recent devices under product code LIN
view allMore clearances from Baxter Healthcare Corp
view all- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
Data sourced from openFDA. This site is unofficial and independent of the FDA.