EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000— 510(k) K923257
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K923257 for EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000, Substantially Equivalent on 1992-09-28. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Em Diagnostic 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
- Gibbstown, NJ, 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 Em Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.