AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM— 510(k) K971103
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K971103 for AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM, Substantially Equivalent on 1997-06-27. Applicant: Tosoh Medics, Inc.. Device class: 1.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code KHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2560
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Recent devices under product code KHO
view allMore clearances from Tosoh Medics, Inc.
view allAdverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
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 K971103
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 K971103.
Data sourced from openFDA. This site is unofficial and independent of the FDA.