DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS— 510(k) K933682
Substantially EquivalentMiles, Inc.
FDA 510(k) clearance K933682 for DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS, Substantially Equivalent on 1994-04-12. Applicant: Miles, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles, 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
- Tarrytown, NY, 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
- 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 Miles, Inc.
view all- K950292 — FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
- K950353 — TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
- K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
- K945655 — CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
- K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.