FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERO-STAT R II STAPHYLOCOCCUS TEST
K Number: K863025
·
Decision Sep 15, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
16
Review Days
35
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Basic Information
- Device Name
- SERO-STAT R II STAPHYLOCOCCUS TEST
- K Number
- K863025
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scott Laboratories, Inc.
- Date Received
- August 11, 1986
- Decision Date
- September 15, 1986
- Product Code
- LHT
- 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 |
|---|---|---|---|
| LHT | Staphylococcus Aureus Somatic Antigens | 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 |
| 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 |
| K811098 | SERO-STAT STAPHYLOCOCCUS TEST | May 5, 1981 | Substantially Equivalent |