Atlas FDA

HISTOPLASMA YEAST ANTI #CF10021X

FDA 510(k) clearance K791393 · decided 1979-08-16

Clearance details

K-number
K791393
Device name
HISTOPLASMA YEAST ANTI #CF10021X
Applicant
Immuno-Mycologics, Inc.
Decision
Substantially Equivalent
Date received
1979-07-11
Decision date
1979-08-16
Days to decision
36 days
Clearance type
Traditional
Product code
GMJ
Device class
2
Regulation number
866.3320
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LA-HISTO ANTIBODY SYSTEM #HL 1001 (K830837)Immuno-Mycologics, Inc.1983-05-05
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (K813359)American Scientific Products1981-12-31
IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130)Nolan Biological Laboratories, Inc.1980-09-26
HISTOPLASMA CAPSULATUM, ANTIGEN (K792701)Meridian Diagnostics, Inc.1980-01-23
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (K792708)Meridian Diagnostics, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (K792704)Meridian Diagnostics, Inc.1980-01-17
HISTOPLASMA CAPSULATUM, ANTISERUM (K792711)Meridian Diagnostics, Inc.1980-01-17
HISTOPLASMA MYCELIAL #CF10020X (K791394)Immuno-Mycologics, Inc.1979-08-16
FUNGAL IMMUNODIFFUSION KIT #ID1001 (K791384)Immuno-Mycologics, Inc.1979-08-16
HISTOPLASMA YEAST ANTIGEN (K760827)I M, Inc.1976-11-01
HISTOPLASMA MYCELIAL ANTIGEN (K760826)I M, Inc.1976-11-01

Recalls involving this device

RecordFirmDate
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and p recall (Z-2040-2016)Immuno-Mycologics, Inc2016-06-20