BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP— 510(k) K082977
Substantially EquivalentMk Bio, Inc.
FDA 510(k) clearance K082977 for BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP, Substantially Equivalent on 2009-08-20. Applicant: Mk Bio, Inc.. Device class: 2.
Clearance details
- Applicant
- Mk Bio, Inc.
- Product code
- Code LDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.