FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
K Number: K883599
·
Decision Sep 2, 1988
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
11
Applicant Total
22
Review Days
10
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Basic Information
- Device Name
- LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
- K Number
- K883599
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3875
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- August 23, 1988
- Decision Date
- September 2, 1988
- Product Code
- IEO
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IEO | Processor, Tissue, Automated | FDA class 1 | Pathology |
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Other Clearances by Innovative Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973035 | VIOLA II DENTAL CAMERA SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K951469 | BAZOOKA SYSTEM | Jun 28, 1995 | Substantially Equivalent |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | Nov 28, 1994 | Substantially Equivalent |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Dec 29, 1992 | Substantially Equivalent |
| K922081 | LABOTECH AUTOMATED MICROTITER ANALYZER | Sep 2, 1992 | Substantially Equivalent |
| K921005 | AUTOLOADER | Apr 29, 1992 | Substantially Equivalent |
| K915457 | PHACO 20/20 SYSTEM I | Feb 24, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent |