FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GONI-KIT
K Number: K852582
·
Decision Jul 12, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
9
Review Days
24
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Basic Information
- Device Name
- GONI-KIT
- K Number
- K852582
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Culture Kits, Inc.
- Date Received
- June 18, 1985
- Decision Date
- July 12, 1985
- Product Code
- JSX
- 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 |
|---|---|---|---|
| JSX | Kit, Identification, Neisseria Gonorrhoeae | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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XACT NEISSERIA
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MODIFIED IDS RAPID NH SYSTEM
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NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
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Other Clearances by Culture Kits, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911846 | URI-THREE(TM), MODIFICATION | Oct 4, 1991 | Substantially Equivalent |
| K854672 | CANDI-KIT TM | Jul 11, 1986 | Substantially Equivalent |
| K853488 | STAPH KIT | Aug 28, 1985 | Substantially Equivalent |
| K851225 | URINE DUO | Aug 13, 1985 | Substantially Equivalent |
| K852480 | DERM-KIT | Jul 9, 1985 | Substantially Equivalent |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Apr 29, 1985 | Substantially Equivalent |
| K850765 | STREP-KIT | Apr 24, 1985 | Substantially Equivalent |
| K850998 | URI-KIT | Apr 1, 1985 | Substantially Equivalent |