TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU— 510(k) K854392
Substantially EquivalentWindsor Laboratories, Inc.
FDA 510(k) clearance K854392 for TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU, Substantially Equivalent on 1985-12-05. Applicant: Windsor Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Windsor Laboratories, Inc.
- Product code
- Code LFW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3900
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garland, TX, US
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