FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY— 510(k) K861716
Substantially EquivalentWhittaker Bioproducts, Inc.
FDA 510(k) clearance K861716 for FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY, Substantially Equivalent on 1986-08-08. Applicant: Whittaker Bioproducts, Inc.. Device class: 1.
Clearance details
- Applicant
- Whittaker Bioproducts, Inc.
- Product code
- Code GRZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3375
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walkersville, MD, US
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