IMMULITE(R) TBG— 510(k) K950072
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K950072 for IMMULITE(R) TBG, Substantially Equivalent on 1995-04-03. Applicant: Diagnostic Products Corp.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code JJX
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
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K950072
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 K950072.
Data sourced from openFDA. This site is unofficial and independent of the FDA.