FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE-TEK III MINI-RAPID PROCESSOR
K Number: K801427
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
11
Applicant Total
158
Review Days
41
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Basic Information
- Device Name
- TISSUE-TEK III MINI-RAPID PROCESSOR
- K Number
- K801427
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3875
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Miles Laboratories, Inc.
- Date Received
- June 17, 1980
- Decision Date
- July 28, 1980
- Product Code
- IEO
- 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 |
|---|---|---|---|
| IEO | Processor, Tissue, Automated | FDA class 1 | Pathology |
Similar 510(k) Clearances
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SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
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LX 300 TISSUE PROCESSOR
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LX120 TISSUE PROCESSOR
FDA 510(k)
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LKB 2189 ULTROPROCESSOR
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Miles Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 | Substantially Equivalent |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | Apr 28, 1988 | Substantially Equivalent |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Apr 5, 1988 | Substantially Equivalent |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Dec 22, 1987 | Substantially Equivalent |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Oct 28, 1987 | Substantially Equivalent |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | Aug 4, 1987 | Substantially Equivalent |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Apr 14, 1987 | Substantially Equivalent |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | Feb 18, 1987 | Substantially Equivalent |