FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO HEMATOCRIT CAPILLARY TUBES
K Number: K843892
·
Decision Nov 13, 1984
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
127
Review Days
41
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Basic Information
- Device Name
- MICRO HEMATOCRIT CAPILLARY TUBES
- K Number
- K843892
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- October 3, 1984
- Decision Date
- November 13, 1984
- Product Code
- GIO
- 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 |
|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | FDA class 1 | Hematology |
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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 |