FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERO-STAT STAPHYLOCOCCUS TEST
K Number: K811098
·
Decision May 5, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
16
Review Days
13
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Basic Information
- Device Name
- SERO-STAT STAPHYLOCOCCUS TEST
- K Number
- K811098
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scott Laboratories, Inc.
- Date Received
- April 22, 1981
- Decision Date
- May 5, 1981
- Product Code
- JWX
- 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 |
|---|---|---|---|
| JWX | Kit, Screening, Staphylococcus Aureus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWX), ordered by most recent decision date.
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
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REMEL STAPH LATEX KIT
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STAPH-A-LEX(TM) SYSTEM
FDA 510(k)
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SLIDEX STAPH-KIT
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K852832 | IDENTICULT-NEISSERIA | Jul 19, 1985 | Substantially Equivalent |
| K852666 | IDENTICULT-AE | Jul 15, 1985 | Substantially Equivalent |
| K841680 | SCOTT SELECTICULT-HSV ISOLATION & | Oct 30, 1984 | Substantially Equivalent |