FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COCCIDIOIDES MYCELIAL ANTIGEN
K Number: K760829
·
Decision Nov 1, 1976
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
41
Review Days
19
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COCCIDIOIDES MYCELIAL ANTIGEN
- K Number
- K760829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3135
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- October 13, 1976
- Decision Date
- November 1, 1976
- Product Code
- GMG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMG), ordered by most recent decision date.
COCCIDIOIDES LATEX AGGLUTINATION
FDA 510(k)
FDA Class 2
·Microbiology
COCCIDIOIDES IMMITIS, LATEX AGGLUTI
FDA 510(k)
FDA Class 2
·Microbiology
COCCIDIODES (COCCI)
FDA 510(k)
FDA Class 2
·Microbiology
REAGENT, COCCI LATEX
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K880753 | UMBILICAL CORD CLAMP | Apr 27, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 8, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K854155 | STERILE SALINE SOLUTION | Dec 10, 1985 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |