FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD COLLECTION TUBE, LAVENDER
K Number: K771052
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
38
Applicant Total
62
Review Days
14
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Basic Information
- Device Name
- BLOOD COLLECTION TUBE, LAVENDER
- K Number
- K771052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- June 13, 1977
- Decision Date
- June 27, 1977
- Product Code
- GIM
- 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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | FDA class 2 | Clinical Chemistry |
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Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |