ROTACLONE ROTAVIRUS DIAGNOSTIC KIT— 510(k) K852969

Name: FDA 510(k) clearance K852969
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Cambridge Bioscience Corp.

FDA 510(k) clearance K852969 for ROTACLONE ROTAVIRUS DIAGNOSTIC KIT, Substantially Equivalent on 1985-11-05. Applicant: Cambridge Bioscience Corp.. Device class: 1.

Clearance details

Applicant: Cambridge Bioscience Corp.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1985-07-15
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIQ

view all

K990842 — SAS ROTA TEST1999-08-09
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K971585 — IMMUNOCARD STAT! ROTAVIRUS1997-08-20
K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

More clearances from Cambridge Bioscience Corp.

view all

K890281 — HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES1989-03-15
K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)1988-07-08
K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST1988-02-24
K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST1988-02-24

Recalls naming K852969

K-number listed on FDA's recall record

Z-0552-2022 — Premier Rotaclone, Rx onlyClass II·Terminated·MEDLINE INDUSTRIES, LP - Northfield·20211201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K852969.

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