ACON ONE STEP PREGNANCY TEST STRIP (URINE)— 510(k) K993203
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K993203 for ACON ONE STEP PREGNANCY TEST STRIP (URINE), Substantially Equivalent on 1999-12-01. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, 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
- San Diego, CA, US
Recent devices under product code JHI
view all- K262299 — Instant-View® hCG Combo II Cassette Test
- K241919 — Innovita HCG Pregnancy Rapid Combo Test
- 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, Inc.
view all- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
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 →
Recalls naming K993203
K-number listed on FDA's recall record- Z-3273-2026 — Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;
- Z-1606-2022 — a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993203.
Data sourced from openFDA. This site is unofficial and independent of the FDA.