Atlas FDA

ELECSYS FOLATE III

FDA 510(k) clearance K141426 · decided 2014-10-17

Clearance details

K-number
K141426
Device name
ELECSYS FOLATE III
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2014-05-30
Decision date
2014-10-17
Days to decision
140 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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AIA-PACK RBC FOLATE (K091332)Tosoh Bioscience, Inc.2009-10-02
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340)Roche Diagnostics Corp.2009-06-19
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774)Beckman Coulter, Inc.2006-04-21
ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292)Roche Diagnostics Corp.2005-06-17
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318)Roche Diagnostics Corp.2004-12-23

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