CLEX— 510(k) K833463

Substantially Equivalent

Dextran Products, Ltd.

FDA 510(k) clearance K833463 for CLEX, Substantially Equivalent on 1983-11-21. Applicant: Dextran Products, Ltd.. Device class: 1.

Clearance details

Applicant: Dextran Products, Ltd.
Product code: Code KIS
Device class: Class 1
Regulation: 21 CFR 864.2800
Advisory panel: Hematology
Date received: 1983-10-05
Decision date: 1983-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIS

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K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-21591988-04-04
K880470 — BOVINE CALF SERUM CATALOG #A-21191988-04-01
K872847 — SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT1987-08-10
K870580 — MLC NORMAL SERUM1987-04-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.