Atlas FDA

IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

FDA 510(k) clearance K150132 · decided 2015-04-13

Clearance details

K-number
K150132
Device name
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2015-01-21
Decision date
2015-04-13
Days to decision
82 days
Clearance type
Traditional
Product code
JJX
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, 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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