FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO-MAT SYSTEM
K Number: K854962
·
Decision Dec 23, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
20
Review Days
12
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Basic Information
- Device Name
- MICRO-MAT SYSTEM
- K Number
- K854962
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.5850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- December 11, 1985
- Decision Date
- December 23, 1985
- Product Code
- GKJ
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GKJ | Spinner, Slide, Automated | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKJ), ordered by most recent decision date.
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AUTOMATED SLIDE SPINNER
FDA 510(k)
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BLOOD-SMEARING INSTRUMENT (MINIPREP TM)
FDA 510(k)
FDA Class 1
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Other Clearances by Ulster Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Jun 22, 1994 | Substantially Equivalent |
| K920562 | UNISTIK | Mar 27, 1992 | Substantially Equivalent |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | Jul 19, 1990 | Substantially Equivalent |
| K895890 | AUTOPEN | Feb 16, 1990 | Substantially Equivalent |
| K894474 | THE AUTOLET LITE | Aug 18, 1989 | Substantially Equivalent |
| K885340 | AIR DISPLACEMENT PIPETTE | Feb 14, 1989 | Substantially Equivalent |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Feb 17, 1988 | Substantially Equivalent |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent |
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |