ST AIA-PACK CEA ENZYME IMMUNOASSAY— 510(k) K023893
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K023893 for ST AIA-PACK CEA ENZYME IMMUNOASSAY, Substantially Equivalent on 2002-12-18. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code DHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South San Francisco, CA, US
Recent devices under product code DHX
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view allRecalls naming K023893
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 K023893.
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