FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
K Number: K812558
·
Decision Sep 29, 1981
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
4
Applicant Total
158
Review Days
21
Basic Information
- Device Name
- TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
- K Number
- K812558
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- MILES LABORATORIES, INC.
- Date Received
- September 8, 1981
- Decision Date
- September 29, 1981
- Product Code
- IDO
- 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 |
|---|---|---|---|
| IDO | Microtome, Rotary | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IDO), ordered by most recent decision date.
LKB 2260 MACROTOME
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FDA 510(k)
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LKB 2230 ROTARY ONE
FDA 510(k)
FDA Class 1
·Pathology
LKB-BROMMA 2218 HISTORANGE MICROTOME
FDA 510(k)
FDA Class 1
·Pathology
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| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
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