THERACHEM-PLUS, TRI-LEVEL TDC (TM)— 510(k) K861185
Substantially EquivalentFisher Scientific Co., LLC
FDA 510(k) clearance K861185 for THERACHEM-PLUS, TRI-LEVEL TDC (TM), Substantially Equivalent on 1986-05-23. Applicant: Fisher Scientific Co., LLC. Device class: 1.
Clearance details
- Applicant
- Fisher Scientific Co., LLC
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Recent devices under product code JJY
view all- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
More clearances from Fisher Scientific Co., LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.