FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XYLENE
K Number: K881282
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
14
Applicant Total
14
Review Days
11
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Basic Information
- Device Name
- XYLENE
- K Number
- K881282
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Anatech, Ltd.
- Date Received
- March 25, 1988
- Decision Date
- April 5, 1988
- Product Code
- KEM
- 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 |
|---|---|---|---|
| KEM | Agent, Clearing | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KEM), ordered by most recent decision date.
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PERMACLEAR SOLUTION CAT. NO. 4950
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XYLENE SUBSTITUTE
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XYLENE SUBSTITUTE MONTANT
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FDA Class 1
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PRO-PAR CLEARANT
FDA 510(k)
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Other Clearances by Anatech, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Jul 28, 1988 | Substantially Equivalent |
| K882874 | ZINC FORMALIN | Jul 28, 1988 | Substantially Equivalent |
| K882268 | ZINC FORMALIN CONCENTRATE | Jun 15, 1988 | Substantially Equivalent |
| K872663 | DRY-FORM | Aug 6, 1987 | Substantially Equivalent |
| K872498 | HARRIS HEMATOXYLIN | Jul 9, 1987 | Substantially Equivalent |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Jul 9, 1987 | Substantially Equivalent |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Jul 9, 1987 | Substantially Equivalent |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Mar 31, 1987 | Substantially Equivalent |
| K842862 | CB FORMALIN | Aug 28, 1984 | Substantially Equivalent |
| K842940 | CBA FORMALIN | Aug 28, 1984 | Substantially Equivalent |