TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY— 510(k) K863345
Substantially EquivalentHybritech, Inc.
FDA 510(k) clearance K863345 for TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1986-10-08. Applicant: Hybritech, Inc.. Device class: 2.
Clearance details
- Applicant
- Hybritech, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Hybritech, Inc.
view allRecalls naming K863345
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 K863345.
Data sourced from openFDA. This site is unofficial and independent of the FDA.