FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FECAL STAINING KIT
K Number: K810875
·
Decision May 1, 1981
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
9
Review Days
31
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Basic Information
- Device Name
- FECAL STAINING KIT
- K Number
- K810875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Jayco Pharmaceuticals
- Date Received
- March 31, 1981
- Decision Date
- May 1, 1981
- Product Code
- KKJ
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KKJ | Sudan Iii | FDA class 1 | Hematology |
Other Clearances by Jayco Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT | Jan 2, 1985 | Substantially Equivalent |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jan 2, 1985 | Substantially Equivalent |
| K844691 | ENDOSCOPIC ASPIRATION CATHETER SET | Jan 2, 1985 | Substantially Equivalent |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Oct 23, 1984 | Substantially Equivalent |
| K842001 | LIVER BIOPSY TRAY | Oct 15, 1984 | Substantially Equivalent |
| K841258 | FOREIGN BODY PROTECTOR | Jul 9, 1984 | Substantially Equivalent |
| K840800 | POLYP-SAVER SLEVE | Mar 23, 1984 | Substantially Equivalent |
| K830781 | ENDO-GUARD | Mar 31, 1983 | Substantially Equivalent |