KINGS BAY PRELUDE ONE STEP HCG COMBO KIT— 510(k) K931698
Substantially EquivalentKing'S Bay Intl., Inc.
FDA 510(k) clearance K931698 for KINGS BAY PRELUDE ONE STEP HCG COMBO KIT, Substantially Equivalent on 1993-11-05. Applicant: King'S Bay Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- King'S Bay Intl., 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
- Vista, CA, US
Recent devices under product code JHI
view all- K262299 — Instant-View® hCG Combo II Cassette Test
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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)
Adverse 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.