IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)— 510(k) K004002
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K004002 for IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600), Substantially Equivalent on 2001-02-14. Applicant: Diagnostic Products Corp..
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.