FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABCO ULTRA SLIDE MICROSCOPE SLIDE
K Number: K800232
·
Decision Feb 21, 1980
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
7
Applicant Total
127
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ABCO ULTRA SLIDE MICROSCOPE SLIDE
- K Number
- K800232
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- February 5, 1980
- Decision Date
- February 21, 1980
- Product Code
- KEW
- 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 |
|---|---|---|---|
| KEW | Slides, Microscope | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KEW), ordered by most recent decision date.
THE CEN-SLIDE(TM) CENTRIFUGE TUBE
FDA 510(k)
FDA Class 1
·Pathology
MICROSCOPE SLIDES PRECOATED
FDA 510(k)
FDA Class 1
·Pathology
MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY
FDA 510(k)
FDA Class 1
·Pathology
SECTIONING AID KIT
FDA 510(k)
FDA Class 1
·Pathology
FROSTED GLASS SLIDES
FDA 510(k)
FDA Class 1
·Pathology
QUANTIMETRIC 2 TEST KIT
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Abco Dealers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | Feb 7, 1991 | Substantially Equivalent |
| K882304 | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) | Jul 12, 1988 | Substantially Equivalent |
| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | Apr 21, 1988 | Substantially Equivalent |
| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |