FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACUETTE (MULTI-USE HOLDER)
K Number: K974873
·
Decision Feb 5, 1998
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
10
Review Days
38
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Basic Information
- Device Name
- VACUETTE (MULTI-USE HOLDER)
- K Number
- K974873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Greiner Meditech, Inc.
- Date Received
- December 29, 1997
- Decision Date
- February 5, 1998
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Greiner Meditech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992145 | ECOMED SCALP VEIN SET | Oct 14, 1999 | Substantially Equivalent |
| K992244 | GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE | Jul 26, 1999 | Substantially Equivalent |
| K991843 | GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE | Jun 25, 1999 | Substantially Equivalent |
| K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | Dec 28, 1998 | Substantially Equivalent |
| K982998 | GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE | Oct 21, 1998 | Substantially Equivalent |
| K982999 | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE | Oct 16, 1998 | Substantially Equivalent |
| K981619 | VACUETTE MULTIPLE SAMPLE LUER ADAPTER | Jul 15, 1998 | Substantially Equivalent |
| K980768 | VACUETTE HOLDEX | Apr 9, 1998 | Substantially Equivalent |
| K973620 | VACUETTE MULTI-SAMPLE NEEDLE | Dec 17, 1997 | Substantially Equivalent |