LYME STAT TEST KIT
FDA 510(k) clearance K875286 · decided 1988-03-30
Clearance details
- K-number
- K875286
- Device name
- LYME STAT TEST KIT
- Applicant
- Whittaker Bioproducts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-29
- Decision date
- 1988-03-30
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- LSR
- Device class
- 2
- Regulation number
- 866.3830
- 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.