IMMU-COUNT 404— 510(k) K822293

Substantially Equivalent

Kemble Instruments, Inc.

FDA 510(k) clearance K822293 for IMMU-COUNT 404, Substantially Equivalent on 1982-08-24. Applicant: Kemble Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Kemble Instruments, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1982-08-02
Decision date: 1982-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Kemble Instruments, Inc.

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K832736 — KEMTEK 104 RIA GAMMA COUNTER1983-09-29

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