ATAC 6000 CHEMISTRY ANALYZER— 510(k) K902689
Substantially EquivalentBio-Chem Laboratories
FDA 510(k) clearance K902689 for ATAC 6000 CHEMISTRY ANALYZER, Substantially Equivalent on 1990-07-10. Applicant: Bio-Chem Laboratories. Device class: 1.
Clearance details
- Applicant
- Bio-Chem Laboratories
- 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
- Lakewood, NJ, US
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- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Bio-Chem Laboratories
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.