Bact/Alert Blood Collection Adapter Cap and Insert
FDA 510(k) K933939 · Organon Teknika Corp.
510(k) numberK933939
Submission
- Device name
- Bact/Alert Blood Collection Adapter Cap and Insert
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- August 12, 1993
- Decision date
- February 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|
| K003104 | Bact/Alert CSRLJF · Traditional | 10/20/2000SE |
| K000492 | Mda D-DimerDAP · Traditional | 06/07/2000SE |
| K000378 | Bact/Alert MB Culture BottleMDB · Traditional | 03/02/2000SE |
| K994343 | Bact/Alert SVMDB · Traditional | 02/10/2000SE |
| K993423 | Bact/Alert SAMDB · Traditional | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | 09/24/1999SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | 09/15/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
Questions and answers
When was Bact/Alert Blood Collection Adapter Cap and Insert cleared by the FDA?
Bact/Alert Blood Collection Adapter Cap and Insert (K933939) received a 510(k) decision of Substantially Equivalent on February 7, 1994, 179 days after the submission was received.
What is the product code of K933939?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.