ISO-DATA 100 SERIES GAMMA COUNTER— 510(k) K872429

Name: FDA 510(k) clearance K872429
Creator: U.S. Food and Drug Administration
Published: 1987-08-21

Substantially Equivalent

Iso-Data, Inc.

FDA 510(k) clearance K872429 for ISO-DATA 100 SERIES GAMMA COUNTER, Substantially Equivalent on 1987-08-21. Applicant: Iso-Data, Inc.. Device class: 1.

Clearance details

Applicant: Iso-Data, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1987-06-22
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rolling Meadows, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJJ

view all

K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR1996-08-16
K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER1995-03-30
K920559 — ABBOTT VERTEX ANALYZER1992-03-19
K900087 — GENESYS 6000 GAMMA COUNTER1990-07-19
K896202 — MATRIX(TM)-961990-01-02

More clearances from Iso-Data, Inc.

view all

K872430 — ISO-DATA 500 SERIES GAMMA COUNTER1987-08-21
K843434 — ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.1984-10-05
K843365 — ISO-DATA IMMUNOASSAY NETWORK SYSTEM1984-09-27
K810631 — DPM CALCULATOR1981-03-27
K780813 — IDI GDR DATA REDUCTION SYSTEM1978-06-28

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