IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5— 510(k) K991797
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K991797 for IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5, Substantially Equivalent on 1999-06-09. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Angeles, CA, US
Recent devices under product code JHX
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- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
More clearances from Diagnostic Products Corp.
view all- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.