RIALYZE VITAMIN B-12 TEST— 510(k) K781410
Substantially EquivalentAmes Div., Miles Laboratories, Inc.
FDA 510(k) clearance K781410 for RIALYZE VITAMIN B-12 TEST, Substantially Equivalent on 1978-09-27. Applicant: Ames Div., Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Ames Div., Miles Laboratories, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.