DNA STAT TEST KIT
FDA 510(k) clearance K843904 · decided 1984-11-01
Clearance details
- K-number
- K843904
- Device name
- DNA STAT TEST KIT
- Applicant
- Whittaker Bioproducts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-03
- Decision date
- 1984-11-01
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- LJM
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.