Atlas FDA

TINA-QUANT ALBUMIN GEN 2

FDA 510(k) clearance K101203 · decided 2010-09-10

Clearance details

K-number
K101203
Device name
TINA-QUANT ALBUMIN GEN 2
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2010-04-29
Decision date
2010-09-10
Days to decision
134 days
Clearance type
Traditional
Product code
DCF
Device class
2
Regulation number
866.5040
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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COBAS 8000 MODULAR SERIES ANALYZER (K100853)Roche Diagnostics Corp.2010-09-09
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486)Kamiya Biomedical Co.2010-04-29
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251)Beckman Coulter, Inc.2009-04-08
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990)Dade Behring, Inc.2006-09-19
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553)Polymedco, Inc.2006-03-09
DCL MICROALBUMIN ASSAY, MODEL 252-20 (K051191)Diagnostic Chemicals , Ltd.2005-07-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01