AMYLASE EPS REAGENT— 510(k) K070064
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K070064 for AMYLASE EPS REAGENT, Substantially Equivalent on 2007-05-22. Applicant: Thermo Fisher Scientific. Device class: 2.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noble Park, AU
Recent devices under product code JFJ
view all- K210633 — Amylase2
- K191454 — Atellica CH Amylase_2 (AMY_2)
- K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
- K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
- K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
More clearances from Thermo Fisher Scientific
view all- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
- K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
Data sourced from openFDA. This site is unofficial and independent of the FDA.