COULTER ACCU-ZYME IIY-GT REAGENT KIT— 510(k) K790812
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K790812 for COULTER ACCU-ZYME IIY-GT REAGENT KIT, Substantially Equivalent on 1979-06-28. Applicant: Coulter Electronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code JPZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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