FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDIDA IMMUNODIFFUSION KIT
K Number: K770527
·
Decision Mar 17, 1978
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
41
Review Days
364
Basic Information
- Device Name
- CANDIDA IMMUNODIFFUSION KIT
- K Number
- K770527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3135
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- I M, INC.
- Date Received
- March 18, 1977
- Decision Date
- March 17, 1978
- Product Code
- GMI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | FDA class 2 | Microbiology |
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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 |