Atlas FDA

AIA-PACK RBC FOLATE

FDA 510(k) clearance K091332 · decided 2009-10-02

Clearance details

K-number
K091332
Device name
AIA-PACK RBC FOLATE
Applicant
Tosoh Bioscience, Inc.
Decision
Substantially Equivalent
Date received
2009-05-06
Decision date
2009-10-02
Days to decision
149 days
Clearance type
Traditional
Product code
CGN
Device class
2
Regulation number
862.1295
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Grove City, OH, US
Third-party review
No
Expedited review
No

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ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340)Roche Diagnostics Corp.2009-06-19
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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
AIA-PACK PSA (P910065/S009)Tosoh Bioscience, Inc.2019-06-18
IMMUNOASAY, PSA (P910065/S008)Tosoh Bioscience, Inc.2012-02-13
ST AIA-PACK PA (P910065/S007)Tosoh Bioscience, Inc.2009-11-30
AIA-PACK PA PSA, ST AIA-PACK PA PSA (P910065/S006)Tosoh Bioscience, Inc.2005-11-30
ST AIA-PACK PA (P910065/S005)Tosoh Bioscience, Inc.2004-05-25
ST AIA-PACK PA (P910065/S004)Tosoh Bioscience, Inc.2003-08-12
AIA-PACK PA (P910065/S003)Tosoh Bioscience, Inc.2002-09-09
AIA PACK PA (P910065/S002)Tosoh Bioscience, Inc.2000-03-03