IMMUNOGLOBULINS G— 510(k) K873870

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K873870 for IMMUNOGLOBULINS G, Substantially Equivalent on 1987-10-13. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1987-08-24
Decision date: 1987-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DEW

K050113 — TINA-QUANT IGG GEN.22005-02-08
K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.22004-03-10
K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT2001-03-15
K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2000-01-18
K993281 — K-ASSAY IGG1999-11-09

More clearances from Unipath , Ltd.

K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST2006-07-03
K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST2006-05-25
K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC2005-12-06
K050930 — E.P.T. CERTAINTY PREGNANCY TEST2005-05-12
K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT2004-09-10

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