RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN— 510(k) K772078

Name: FDA 510(k) clearance K772078
Creator: U.S. Food and Drug Administration
Published: 1978-02-03

Substantially Equivalent

Gelman Instrument Co.

FDA 510(k) clearance K772078 for RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN, Substantially Equivalent on 1978-02-03. Applicant: Gelman Instrument Co.. Device class: 2.

Clearance details

Applicant: Gelman Instrument Co.
Product code: Code DAB
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1977-11-03
Decision date: 1978-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAB

view all

K913670 — HAPTOGLOBIN IMMUNOLOGICAL TEST KIT1991-12-09
K843570 — FIAX HAPTOGLOBIN TEST KIT1984-10-05

More clearances from Gelman Instrument Co.

view all

K772073 — RADIAL IMMUNODIFFUSION KIT-COMP. 31978-02-03
K772074 — RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN1978-02-03
K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT1978-02-03
K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.1978-02-03
K772077 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G1978-02-03

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