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
- 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
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- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
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.