SERA-TEK MICROSOMAL ANTIBODY TEST— 510(k) K865053
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K865053 for SERA-TEK MICROSOMAL ANTIBODY TEST, Substantially Equivalent on 1987-02-18. Applicant: Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code JZO
view allMore clearances from Miles Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.