FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CUSTOM OPEN HEART TRAY
K Number: K850072
·
Decision Mar 15, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
27
Review Days
65
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Basic Information
- Device Name
- CUSTOM OPEN HEART TRAY
- K Number
- K850072
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Pro-Lab, Inc.
- Date Received
- January 9, 1985
- Decision Date
- March 15, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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| 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 |
| K861142 | MASTER KIT B | Jul 10, 1986 | Unknown |