Atlas FDA

TINA-QUANT IGG GEN.2

FDA 510(k) clearance K050113 · decided 2005-02-08

Clearance details

K-number
K050113
Device name
TINA-QUANT IGG GEN.2
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2005-01-18
Decision date
2005-02-08
Days to decision
21 days
Clearance type
Traditional
Product code
DEW
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, 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
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434)Roche Diagnostics Corp.2004-03-10
SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617)Helena Laboratories2001-03-15
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928)Wako Chemicals USA, Inc.2000-01-18
K-ASSAY IGG (K993281)Kamiya Biomedical Co.1999-11-09
IGG (K983221)Abbott Laboratories1998-11-04
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (K965108)Beckman Instruments, Inc.1997-03-06
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974)Beckman Instruments, Inc.1997-03-06
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868)Beckman Instruments, Inc.1997-02-10
QUANTEX IGG (K962202)Instrumentation Laboratory CO1996-09-26
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (K955798)Randox Laboratories, Ltd.1996-04-05
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL (K951635)Beckman Instruments, Inc.1995-05-15
BEHRING NEPHELOMETER II (K943997)Behring Diagnostics, Inc.1994-10-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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