ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST— 510(k) K980736
Substantially EquivalentAcon Laboratories Co.
FDA 510(k) clearance K980736 for ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST, Substantially Equivalent on 1998-04-16. Applicant: Acon Laboratories Co.. Device class: 2.
Clearance details
- Applicant
- Acon Laboratories Co.
- 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
- Bethlehem, PA, US
Recent devices under product code JHI
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- K203272 — Alltest Pregnancy Rapid Combo Test Cassette
- K172322 — Atellica IM Total hCG (ThCG)
- K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
More clearances from Acon Laboratories Co.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.