FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAPILLARY TUBE, BLOOD COLLECTION
K Number: K885138
·
Decision Feb 7, 1989
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
10
Review Days
54
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Basic Information
- Device Name
- CAPILLARY TUBE, BLOOD COLLECTION
- K Number
- K885138
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Coeur Laboratories, Inc.
- Date Received
- December 15, 1988
- Decision Date
- February 7, 1989
- 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 |
Similar 510(k) Clearances
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Other Clearances by Coeur Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | Oct 8, 1997 | Substantially Equivalent |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Mar 28, 1997 | Substantially Equivalent |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | Sep 12, 1996 | Substantially Equivalent |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | Jun 22, 1989 | Substantially Equivalent |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | Jan 31, 1989 | Substantially Equivalent |
| K881646 | UROLOGICAL CATHETER | Jun 16, 1988 | Substantially Equivalent |
| K874579 | COEUR CONTROL SYRINGE | Jan 19, 1988 | Substantially Equivalent |
| K873597 | TUBING, POLYETHYLENE | Nov 12, 1987 | Substantially Equivalent |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | Feb 18, 1983 | Substantially Equivalent |