PREGNANCY-SKREEN— 510(k) K050328
Substantially EquivalentBiochemical Diagnostic, Inc.
FDA 510(k) clearance K050328 for PREGNANCY-SKREEN, Substantially Equivalent on 2005-03-29. Applicant: Biochemical Diagnostic, Inc.. Device class: 1.
Clearance details
- Applicant
- Biochemical Diagnostic, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edgewood, NY, US
Recent devices under product code JJX
view allMore clearances from Biochemical Diagnostic, Inc.
view allAdverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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 K050328
K-number listed on FDA's recall record- Z-1312-2024 — Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
- Z-0328-2016 — CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.