BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT— 510(k) K943754
Substantially EquivalentBionostics, Inc.
FDA 510(k) clearance K943754 for BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT, Substantially Equivalent on 1994-09-14. Applicant: Bionostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Bionostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
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