IMMULITE CEA— 510(k) K970877
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K970877 for IMMULITE CEA, Substantially Equivalent on 1997-09-22. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code DHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code DHX
view allMore 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
Recalls naming K970877
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970877.
Data sourced from openFDA. This site is unofficial and independent of the FDA.