FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
MASTER KIT B
K Number: K861142
·
Decision Jul 10, 1986
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
27
Review Days
106
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Basic Information
- Device Name
- MASTER KIT B
- K Number
- K861142
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Pro-Lab, Inc.
- Date Received
- March 26, 1986
- Decision Date
- July 10, 1986
- Product Code
- LRP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Pro-Lab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | Jan 27, 1995 | Substantially Equivalent |
| K914419 | AMNIOTEST(TM) | Sep 1, 1993 | Substantially Equivalent |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Jul 28, 1992 | Substantially Equivalent |
| K903714 | E. COLI 0157 LATEX TEST | Jan 24, 1991 | Substantially Equivalent |
| K894221 | ROSCO PYRR | Sep 28, 1989 | Substantially Equivalent |
| K883995 | X-ACT UREA/TDA | Oct 12, 1988 | Substantially Equivalent |
| K883996 | X-ACT LDC/IND | Oct 12, 1988 | Substantially Equivalent |
| K871121 | PROTECT T.M. | Apr 14, 1987 | Substantially Equivalent |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 | Substantially Equivalent |
| K861888 | HIPPURATE HYDROLYSIS TEST | Jun 3, 1986 | Substantially Equivalent |