ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE— 510(k) K041946
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K041946 for ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE, Substantially Equivalent on 2004-08-16. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, 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
- San Diego, 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
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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.