CLINITEK HCG TEST STRIPS— 510(k) K971209
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K971209 for CLINITEK HCG TEST STRIPS, Substantially Equivalent on 1997-04-04. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- 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
- Elkhart, IN, US
Recent devices under product code JHI
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- 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)
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
More clearances from Bayer Corp.
view all- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
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.