FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IDENTICULT-NEISSERIA
K Number: K852832
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
16
Review Days
17
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Basic Information
- Device Name
- IDENTICULT-NEISSERIA
- K Number
- K852832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scott Laboratories, Inc.
- Date Received
- July 2, 1985
- Decision Date
- July 19, 1985
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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Other Clearances by Scott Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880694 | B. CAT CONFIRM | Jun 16, 1988 | Substantially Equivalent |
| K874933 | MUG-INDOLE DISC | Jan 5, 1988 | Substantially Equivalent |
| K874662 | MYCO-FLUOR REAGENT A & B | Nov 25, 1987 | Substantially Equivalent |
| K873509 | IDENTICULT-BL | Oct 15, 1987 | Substantially Equivalent |
| K871238 | ANABAG | Apr 3, 1987 | Substantially Equivalent |
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | Sep 15, 1986 | Substantially Equivalent |
| K852869 | SELECTICULT-CHLAMYDIA | Sep 19, 1985 | Substantially Equivalent |
| K852666 | IDENTICULT-AE | Jul 15, 1985 | Substantially Equivalent |
| K841680 | SCOTT SELECTICULT-HSV ISOLATION & | Oct 30, 1984 | Substantially Equivalent |
| K811098 | SERO-STAT STAPHYLOCOCCUS TEST | May 5, 1981 | Substantially Equivalent |