FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PARAFFIN EMBEDDING MEDIUM
K Number: K810568
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
10
Applicant Total
30
Review Days
14
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Basic Information
- Device Name
- PARAFFIN EMBEDDING MEDIUM
- K Number
- K810568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath Medical Industries, Inc.
- Date Received
- March 3, 1981
- Decision Date
- March 17, 1981
- Product Code
- KEO
- Advisory Committee
- Pathology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KEO | Formulations, Paraffin, All | FDA class 1 | Pathology |
Similar 510(k) Clearances
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MICRO THIN* PARAFFIN
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TECHNICON PARACUT
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Other Clearances by Surgipath Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883217 | SCHIFF REAGENT | Aug 5, 1988 | Substantially Equivalent |
| K881921 | C-E BRUSH | Jul 19, 1988 | Substantially Equivalent |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | May 25, 1988 | Substantially Equivalent |
| K881659 | TISSUE SECTION ADHESIVE | Apr 21, 1988 | Substantially Equivalent |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Sep 30, 1986 | Substantially Equivalent |
| K863616 | KNIFE MAKER | Sep 25, 1986 | Substantially Equivalent |
| K863548 | ROTARY MICROTOME | Sep 19, 1986 | Substantially Equivalent |
| K863483 | CASSETTE EMBOSSEER | Sep 16, 1986 | Substantially Equivalent |
| K863145 | CERVICAL SCRAPERS | Aug 19, 1986 | Substantially Equivalent |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Apr 11, 1986 | Substantially Equivalent |