AMES SERA-PAK HEMOGLOBIN REAGENT— 510(k) K803248
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K803248 for AMES SERA-PAK HEMOGLOBIN REAGENT, Substantially Equivalent on 1981-01-26. Applicant: Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code KHG
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KHG
view allMore clearances from Miles Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.