SCS-1000 (SYSMEX CALIBRATOR SYSTEM)— 510(k) K943268

Name: FDA 510(k) clearance K943268
Creator: U.S. Food and Drug Administration
Published: 1994-12-15

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K943268 for SCS-1000 (SYSMEX CALIBRATOR SYSTEM), Substantially Equivalent on 1994-12-15. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code KSA
Device class: Class 2
Regulation: 21 CFR 864.8185
Advisory panel: Hematology
Date received: 1994-07-07
Decision date: 1994-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omaha, NE, US

Download summary PDF View on FDA.gov ↗

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