Cryobiological Freezer
FDA 510(k) K881465 · Cryodyne Technologies, Inc.
510(k) numberK881465
Submission
- Device name
- Cryobiological Freezer
- Applicant
- Cryodyne Technologies, Inc.
Soquel, CA, US - Received
- April 6, 1988
- Decision date
- April 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSP – Apparatus, Cell-Freezing And Reagents
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.9225
- Specialty
- Hematology
More from Cryodyne Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926464 | L.C.S.3000GEH · Traditional | 08/24/1993SE |
| K932520 | Calibration GasBXK · Traditional | 08/19/1993SE |
| K881467 | Microscope Stage HeaterKEJ · Traditional | 04/18/1988SE |
| K881466 | Cell-Culture ShakerKJB · Traditional | 04/18/1988SE |
| K860738 | CTC 30, 40, 1 Liquid Oxygen LitersBYJ · Traditional | 08/06/1986SE |
Questions and answers
When was Cryobiological Freezer cleared by the FDA?
Cryobiological Freezer (K881465) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 15 days after the submission was received.
What is the product code of K881465?
The FDA product code is KSP – Apparatus, Cell-Freezing And Reagents, a Class I (low risk) device regulated under 21 CFR 864.9225.