ASPERGILLUS MYCELIAL ANTIGEN— 510(k) K760830

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K760830 for ASPERGILLUS MYCELIAL ANTIGEN, Substantially Equivalent on 1976-11-01. Applicant: I M, Inc.. Device class: 1.

Clearance details

Applicant: I M, Inc.
Product code: Code JWT
Device class: Class 1
Regulation: 21 CFR 866.3040
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 JWT

K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL1981-10-20
K792700 — ASPERGILLUS SP, COMPLEMENT FIXATION1980-01-17
K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X1979-08-16
K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU1979-05-31

More clearances from I M, Inc.

K914600 — NEUROLOGICAL SPONGE1992-12-30
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K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

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