ULTRA ZYME PLUS GOT #64953, 65033 & 34— 510(k) K812592
Substantially EquivalentHarleco
FDA 510(k) clearance K812592 for ULTRA ZYME PLUS GOT #64953, 65033 & 34, Substantially Equivalent on 1981-09-24. Applicant: Harleco. Device class: 2.
Clearance details
- Applicant
- Harleco
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CIT
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- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K071580 — AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
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More clearances from Harleco
view allData sourced from openFDA. This site is unofficial and independent of the FDA.