WELL TYPE GAMMA COUNTER— 510(k) K771613

Substantially Equivalent

Actus, Inc.

FDA 510(k) clearance K771613 for WELL TYPE GAMMA COUNTER, Substantially Equivalent on 1978-04-10. Applicant: Actus, Inc.. Device class: 1.

Clearance details

Applicant: Actus, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1977-08-23
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K920559 — ABBOTT VERTEX ANALYZER1992-03-19
K900087 — GENESYS 6000 GAMMA COUNTER1990-07-19
K896202 — MATRIX(TM)-961990-01-02

More clearances from Actus, Inc.

K771614 — AUTO. WELL TYPE GAMMA COUNTERS1978-04-12
K771612 — WELL TYPE GAMMA COUNTER1978-04-10
K771301 — DIGITAL RADIATION DETECTOR1977-08-04

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