FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPRAY, SYNTHETIC SMEAR
K Number: K803050
·
Decision Dec 30, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- SPRAY, SYNTHETIC SMEAR
- K Number
- K803050
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Products, Inc.
- Date Received
- December 2, 1980
- Decision Date
- December 30, 1980
- Product Code
- IFI
- 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 |
|---|---|---|---|
| IFI | Sprays, Synthetic, Smear | FDA class 1 | Pathology |
Other Clearances by Laboratory Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832588 | CIN AGAR | Sep 12, 1983 | Substantially Equivalent |
| K803051 | FLAME PHOTOMETRY REAGENTS | Jan 9, 1981 | Substantially Equivalent |
| K803013 | CHLORIDE/TCO2 ANALYZER REAGENTS | Jan 2, 1981 | Substantially Equivalent |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | Mar 19, 1980 | Substantially Equivalent |
| K792482 | CHEMISTRY ANALYZER REAGENTS | Jan 11, 1980 | Substantially Equivalent |
| K792481 | CULTURE PLATES & TUBED MEDIA | Dec 31, 1979 | Substantially Equivalent |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Dec 18, 1979 | Substantially Equivalent |