DADE INNOVIN— 510(k) K974343
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K974343 for DADE INNOVIN, Substantially Equivalent on 1998-07-22. Applicant: Dade Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Intl., Inc.
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code GJS
view allMore clearances from Dade Intl., Inc.
view all- K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
- K973974 — DADE TRU-LIQUID CARDIAC CONTROL
- K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR
- K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
Adverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.