QUICK-COUNT HEMATOLOGY REAGENT KIT— 510(k) K833972

Name: FDA 510(k) clearance K833972
Creator: U.S. Food and Drug Administration
Published: 1984-02-17

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K833972 for QUICK-COUNT HEMATOLOGY REAGENT KIT, Substantially Equivalent on 1984-02-17. Applicant: Seragen Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1983-11-16
Decision date: 1984-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K882267 — SYSMEX QUICKLYSER-II (QLS-200A)1988-07-12
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

More clearances from Seragen Diagnostics, Inc.

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K872148 — VIVID CHLAMYDIA(TM)1987-08-19
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K852260 — QUICK-CHEM CALIBRATION SET1985-07-22
K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)1985-06-25
K851521 — LD-1(IMMUNO) SEPARATION SET1985-05-10

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