Immunicon Cellsave Preservative Tube
FDA 510(k) K030596 · Immunicon Corp.
510(k) numberK030596
Submission
- Device name
- Immunicon Cellsave Preservative Tube
- Applicant
- Immunicon Corp.
Huntingdon Valley, PA, US - Received
- February 25, 2003
- Decision date
- August 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
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|---|---|---|
| K060110 | Celltracks Analyzer IINQI · Traditional | 03/16/2006SE |
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| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | 03/12/2004SE |
| K030263 | Immunicon Celltracks AnalyzerGKZ · Traditional | 11/24/2003SE |
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Questions and answers
When was Immunicon Cellsave Preservative Tube cleared by the FDA?
Immunicon Cellsave Preservative Tube (K030596) received a 510(k) decision of Substantially Equivalent on August 8, 2003, 164 days after the submission was received.
What is the product code of K030596?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.