FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABCO MIDSTREAM URINE COLLECTION SET
K Number: K800233
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
288
Registration Numbers
288
Same Product Code
22
Applicant Total
127
Review Days
21
Basic Information
- Device Name
- ABCO MIDSTREAM URINE COLLECTION SET
- K Number
- K800233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- ABCO DEALERS, INC.
- Date Received
- February 5, 1980
- Decision Date
- February 26, 1980
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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Other Clearances by ABCO DEALERS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |