IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6— 510(k) K000257
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K000257 for IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6, Substantially Equivalent on 2000-02-23. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code JFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code JFH
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- 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.