IMMO PHASE, THYROID HORMONE— 510(k) K781409
Substantially EquivalentCorning Medical & Scientific
FDA 510(k) clearance K781409 for IMMO PHASE, THYROID HORMONE, Substantially Equivalent on 1978-09-27. Applicant: Corning Medical & Scientific. Device class: 2.
Clearance details
- Applicant
- Corning Medical & Scientific
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JLW
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- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
More clearances from Corning Medical & Scientific
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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.