IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)— 510(k) K012312
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K012312 for IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS), Substantially Equivalent on 2001-08-20. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code KLB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3900
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code KLB
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- 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.