FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WESCOR 7100 AEROSPRAY SLIDE STAINER
K Number: K833295
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
13
Review Days
38
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Basic Information
- Device Name
- WESCOR 7100 AEROSPRAY SLIDE STAINER
- K Number
- K833295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Wescor, Inc.
- Date Received
- September 23, 1983
- Decision Date
- October 31, 1983
- Product Code
- KPA
- Advisory Committee
- Pathology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KPA | Slide Stainer, Automated | FDA class 1 | Pathology |
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Other Clearances by Wescor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | Mar 27, 2013 | Substantially Equivalent |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | Mar 20, 2001 | Substantially Equivalent |
| K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | May 24, 1988 | Substantially Equivalent |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | May 13, 1988 | Substantially Equivalent |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | Apr 18, 1988 | Substantially Equivalent |
| K880544 | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY | Apr 1, 1988 | Substantially Equivalent |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | Oct 16, 1985 | Substantially Equivalent |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Mar 30, 1984 | Substantially Equivalent |
| K834208 | COLLOID OSMOMETER 4400 | Mar 23, 1984 | Substantially Equivalent |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | Mar 19, 1984 | Substantially Equivalent |