FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUAD FERM +
K Number: K853544
·
Decision Sep 5, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
57
Review Days
10
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Basic Information
- Device Name
- QUAD FERM +
- K Number
- K853544
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Analytical Products, Inc.
- Date Received
- August 26, 1985
- Decision Date
- September 5, 1985
- Product Code
- JSX
- 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 |
|---|---|---|---|
| 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 Analytical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | Mar 11, 1993 | Substantially Equivalent |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | Dec 3, 1992 | Substantially Equivalent |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | Oct 13, 1992 | Substantially Equivalent |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Sep 10, 1990 | Substantially Equivalent |
| K901390 | DMAC INDOLE REAGENT | Apr 16, 1990 | Substantially Equivalent |
| K895796 | API UNISCEPT KB | Nov 13, 1989 | Substantially Equivalent |
| K884510 | MODIFICATION MICRO-MIC | Nov 22, 1988 | Substantially Equivalent |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | Nov 22, 1988 | Substantially Equivalent |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | Mar 23, 1988 | Substantially Equivalent |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | Dec 9, 1987 | Substantially Equivalent |