CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL— 510(k) K912027
Substantially EquivalentEnzyme Technology, Inc.
FDA 510(k) clearance K912027 for CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL, Substantially Equivalent on 1992-01-30. Applicant: Enzyme Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Enzyme Technology, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code CIC
view all- K130870 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
- K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
- K070249 — ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
- K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
- K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
More clearances from Enzyme Technology, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.