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DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k) clearance K092283 · decided 2009-10-21

Clearance details

K-number
K092283
Device name
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-07-29
Decision date
2009-10-21
Days to decision
84 days
Clearance type
Traditional
Product code
DFZ
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081)The Binding Site, Ltd.2002-06-17
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823)Sanquin Blood Supply Foundation2002-05-14
BOEHRINGER MANNHEIM IGG ASSAY (K955906)Boehringer Mannheim Corp.1996-02-09
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422)The Binding Site, Ltd.1994-05-27
H-103 IGG, H-104 IGA, H-105 IGM (K812821)Immulok, Inc.1981-10-26
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (K803272)Icl Scientific1981-01-26
ANTISERA TO RABBIT IMMUNOGLOBULIN (K790720)Kent Laboratories, Inc.1979-08-16
ANTISERUM TO RABBIT IMMUNOGLOBULIN (K790709)Kent Laboratories, Inc.1979-08-16

Recalls involving this device

No recalls on record reference this clearance.

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