AIA-PACK B12 ASSAY— 510(k) K964348
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K964348 for AIA-PACK B12 ASSAY, Substantially Equivalent on 1997-01-13. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- 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 K964348
K-number listed on FDA's recall record- Z-0745-2020 — AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
- Z-0671-2019 — AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964348.
Data sourced from openFDA. This site is unofficial and independent of the FDA.