HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY— 510(k) K130685
Substantially EquivalentHitachi Chemical Diagnostics, Inc.
FDA 510(k) clearance K130685 for HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY, Substantially Equivalent on 2013-08-09. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- 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
- Los Angeles, CA, US
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
- K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
- K091846 — SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
More clearances from Hitachi Chemical Diagnostics, Inc.
view all- K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle
- K182793 — AP3600 Automated Instrument
- K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
- K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
Data sourced from openFDA. This site is unofficial and independent of the FDA.