FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K Number: K780526
·
Decision Apr 28, 1978
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
9
Applicant Total
41
Review Days
28
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Basic Information
- Device Name
- CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
- K Number
- K780526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- March 31, 1978
- Decision Date
- April 28, 1978
- Product Code
- GMD
- 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 |
|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | FDA class 2 | Microbiology |
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FDA 510(k)
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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 |