BOEHRINGER MANNHEIM IGG ASSAY— 510(k) K955906
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K955906 for BOEHRINGER MANNHEIM IGG ASSAY, Substantially Equivalent on 1996-02-09. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code DFZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DFZ
view all- K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
- K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
- K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
- K940422 — IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
- K812821 — H-103 IGG, H-104 IGA, H-105 IGM
More clearances from Boehringer Mannheim Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.