HISTOPLASMA MYCELIAL ANTIGEN— 510(k) K760826

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K760826 for HISTOPLASMA MYCELIAL ANTIGEN, Substantially Equivalent on 1976-11-01. Applicant: I M, Inc.. Device class: 2.

Clearance details

Applicant: I M, Inc.
Product code: Code GMJ
Device class: Class 2
Regulation: 21 CFR 866.3320
Advisory panel: Microbiology
Date received: 1976-10-13
Decision date: 1976-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GMJ

K830837 — LA-HISTO ANTIBODY SYSTEM #HL 10011983-05-05
K813359 — MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL1981-12-31
K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM1980-09-26
K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN1980-01-23
K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST1980-01-17

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.