Blood Collection Tube, Lavender
FDA 510(k) K771052 · Sherwood Medical Industries
510(k) numberK771052
Submission
- Device name
- Blood Collection Tube, Lavender
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- June 13, 1977
- Decision date
- June 27, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
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Questions and answers
When was Blood Collection Tube, Lavender cleared by the FDA?
Blood Collection Tube, Lavender (K771052) received a 510(k) decision of Substantially Equivalent on June 27, 1977, 14 days after the submission was received.
What is the product code of K771052?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.