TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY— 510(k) K870521
Substantially EquivalentHybritech, Inc.
FDA 510(k) clearance K870521 for TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY, Substantially Equivalent on 1987-04-08. Applicant: Hybritech, Inc.. Device class: 2.
Clearance details
- Applicant
- Hybritech, Inc.
- Product code
- Product code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- 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 allAdverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K870521
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 K870521.
Data sourced from openFDA. This site is unofficial and independent of the FDA.