Atlas FDA

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

FDA 510(k) clearance K034055 · decided 2004-01-21

Clearance details

K-number
K034055
Device name
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
Applicant
Diagnostic Products Corp.
Decision
Substantially Equivalent
Date received
2003-12-30
Decision date
2004-01-21
Days to decision
22 days
Clearance type
Special
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Los Angeles, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- T recall (Z-1274-2012)Siemens Healthcare Diagnostics2012-03-21