Atlas FDA

ISE INDIRECT NA, K, C1 FOR GEN 2

FDA 510(k) clearance K140373 · decided 2014-05-22

Clearance details

K-number
K140373
Device name
ISE INDIRECT NA, K, C1 FOR GEN 2
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2014-02-14
Decision date
2014-05-22
Days to decision
97 days
Clearance type
Traditional
Product code
JGS
Device class
2
Regulation number
862.1665
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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.

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