ACCUVETTE II— 510(k) K760197

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K760197 for ACCUVETTE II, Substantially Equivalent on 1976-07-19. Applicant: Coulter Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code JRI
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1976-07-06
Decision date: 1976-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRI

K873656 — MEDATRON CUVETTE DISC1987-12-14
K780888 — THERMO SET ELECTRONIC TEM. CONTROLLER1978-06-28
K760769 — TEMPERATURE REGULATED FIVE CELL HOLDERS1976-11-30

More clearances from Coulter Electronics, Inc.

K923951 — CD8 CYTOSPHERES KIT1994-04-25
K930119 — COULTER RETIC-C CELL CONTROL1993-04-05
K921279 — CD4 CYTOSPHERES KIT1992-12-29
K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

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