MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000— 510(k) K853391
Substantially EquivalentEiken Chemical Co., Inc.
FDA 510(k) clearance K853391 for MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000, Substantially Equivalent on 1985-10-01. Applicant: Eiken Chemical Co., Inc.. Device class: 1.
Clearance details
- Applicant
- Eiken Chemical Co., Inc.
- Product code
- Code JJE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Venice, CA, US
Recent devices under product code JJE
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- K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Eiken Chemical Co., Inc.
view allAdverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
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.