FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
K Number: K953994
·
Decision Sep 26, 1995
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
15
Review Days
33
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Basic Information
- Device Name
- SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
- K Number
- K953994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton Dickinson Vacutainer Systems
- Date Received
- August 24, 1995
- Decision Date
- September 26, 1995
- 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 Becton Dickinson Vacutainer Systems
| K Number | Device Name | ||
|---|---|---|---|
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | Nov 2, 2000 | Substantially Equivalent |
| K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | Jul 28, 1999 | Substantially Equivalent |
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | May 28, 1999 | Substantially Equivalent |
| K991120 | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | May 19, 1999 | Substantially Equivalent |
| K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | Oct 28, 1998 | Substantially Equivalent |
| K982922 | VACUTAINER BRAND BLOOD COLLECTION SYRINGE | Sep 22, 1998 | Substantially Equivalent |
| K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | Jun 17, 1998 | Substantially Equivalent for Some Indications |
| K972075 | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Feb 24, 1998 | Substantially Equivalent |
| K980098 | VACUTAINER BRAND PRONTO NEEDLES HOLDER | Feb 5, 1998 | Substantially Equivalent |
| K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | Jun 17, 1997 | Substantially Equivalent |