CANDIDA IMMUNODIFFUSION KIT— 510(k) K770527

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K770527 for CANDIDA IMMUNODIFFUSION KIT, Substantially Equivalent on 1978-03-17. Applicant: I M, Inc.. Device class: 2.

Clearance details

Applicant: I M, Inc.
Product code: Code GMI
Device class: Class 2
Regulation: 21 CFR 866.3135
Advisory panel: Microbiology
Date received: 1977-03-18
Decision date: 1978-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMI

K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL1989-10-31
K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM1981-08-31
K812185 — FUNGAL IMMUNODIFFUSION SYSTEM1981-08-25
K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL1980-09-26
K792716 — CANDIDA ALBICANS, ANTIGEN1980-01-24

More clearances from I M, Inc.

K914600 — NEUROLOGICAL SPONGE1992-12-30
K892389 — BIOPSY KIT1989-07-17
K881363 — SYRINGE PREFILLED WITH WATER1988-06-23
K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

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