QUICK-COUNT PLUS 2— 510(k) K841504

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K841504 for QUICK-COUNT PLUS 2, Substantially Equivalent on 1984-06-11. Applicant: Seragen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1984-04-10
Decision date: 1984-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Seragen Diagnostics, Inc.

K872148 — VIVID CHLAMYDIA(TM)1987-08-19
K851663 — QUICK-COUNT HEMATOLOGY CONTROLS1985-07-23
K852260 — QUICK-CHEM CALIBRATION SET1985-07-22
K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)1985-06-25
K851521 — LD-1(IMMUNO) SEPARATION SET1985-05-10

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