REAGENT SET, SGPT SERUM GLUTAMIC— 510(k) K781726
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K781726 for REAGENT SET, SGPT SERUM GLUTAMIC, Substantially Equivalent on 1978-11-03. Applicant: Medical Analysis Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CKA
view all- K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
- K113382 — ACE ALT REAGENT
- K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
- K020487 — CARESIDE ALT
- K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
More clearances from Medical Analysis Systems, Inc.
view all- K042717 — MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
- K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
- K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
- K032826 — MAS PAR TDM
- K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
Data sourced from openFDA. This site is unofficial and independent of the FDA.