TEK-CHEK-2— 510(k) K771713
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K771713 for TEK-CHEK-2, Substantially Equivalent on 1977-10-18. Applicant: Miles Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code JJW
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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