FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HISTO-CHECK ACID FAST SLIDES
K Number: K883568
·
Decision Oct 6, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
26
Applicant Total
11
Review Days
45
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Basic Information
- Device Name
- HISTO-CHECK ACID FAST SLIDES
- K Number
- K883568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Val Tech Diagnostics, Inc.
- Date Received
- August 22, 1988
- Decision Date
- October 6, 1988
- Product Code
- LJG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LJG | Quality Control Slides | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJG), ordered by most recent decision date.
MICROSPORIDIUM CONTROL SET
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MICROSPORIDIUM CONTROL SLIDE
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GRAM STAIN CONTROL SLIDE
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BION DIRECT IDENTIFICATION CONTROL SLIDE
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HISTO-CHECK FUNGAL CONTROL SLIDES
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Val Tech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883684 | HERPES VIRUS CONTROL SLIDES | Sep 28, 1988 | Substantially Equivalent |
| K883232 | HISTONE REACTIVE ANA | Sep 7, 1988 | Substantially Equivalent |
| K883208 | HISTO-CHECK SLIDES | Aug 25, 1988 | Substantially Equivalent |
| K871395 | DUAL SUBSTRATE ANA | Apr 20, 1987 | Substantially Equivalent |
| K864668 | ANA TEST KIT | Mar 12, 1987 | Substantially Equivalent |
| K870732 | RAT LIVER NUCLEI TEST SYSTEM | Mar 10, 1987 | Substantially Equivalent |