AIA-PACK MYOGLOBIN ASSAY— 510(k) K981012
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K981012 for AIA-PACK MYOGLOBIN ASSAY, Substantially Equivalent on 1998-05-28. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
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More clearances from Tosoh Medics, Inc.
view allRecalls naming K981012
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 K981012.
Data sourced from openFDA. This site is unofficial and independent of the FDA.