FIAX EB VCA-M TEST KIT
FDA 510(k) clearance K894932 · decided 1989-10-16
Clearance details
- K-number
- K894932
- Device name
- FIAX EB VCA-M TEST KIT
- Applicant
- Whittaker Bioproducts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-03
- Decision date
- 1989-10-16
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- LSE
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walkersville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.