PROCHEQ 1 & 2— 510(k) K944059
Substantially EquivalentPrisma Systems
FDA 510(k) clearance K944059 for PROCHEQ 1 & 2, Substantially Equivalent on 1994-11-15. Applicant: Prisma Systems. Device class: 1.
Clearance details
- Applicant
- Prisma Systems
- 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
- Rome, NY, US
Recent devices under product code JJY
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- 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 Prisma Systems
view allData sourced from openFDA. This site is unofficial and independent of the FDA.