AIA-PACK CK-MB— 510(k) K913298
Substantially EquivalentTosoh Corp.
FDA 510(k) clearance K913298 for AIA-PACK CK-MB, Substantially Equivalent on 1991-09-27. Applicant: Tosoh Corp.. Device class: 2.
Clearance details
- Applicant
- Tosoh Corp.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, D.C., DC, US
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- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
More clearances from Tosoh Corp.
view allRecalls naming K913298
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 K913298.
Data sourced from openFDA. This site is unofficial and independent of the FDA.