Atlas FDA

ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190

FDA 510(k) clearance K090939 · decided 2009-06-18

Clearance details

K-number
K090939
Device name
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2009-04-03
Decision date
2009-06-18
Days to decision
76 days
Clearance type
Traditional
Product code
DKB
Device class
2
Regulation number
862.3200
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
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Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
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