Iec CENTRA-7 Centrifuge Model 2362
FDA 510(k) K782124 · Damon Corp.
510(k) numberK782124
Submission
- Device name
- Iec CENTRA-7 Centrifuge Model 2362
- Applicant
- Damon Corp.
Mchenry, IL, US - Received
- December 27, 1978
- Decision date
- February 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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| K802661 | Liquisol Testosterone Radioimm. Test KitCDZ · Traditional | 12/10/1980SE |
| K790250 | Liquisol Cortisol Ria Test Kit · Traditional | 04/04/1979SE |
| K781012 | Ria Test Kit Sys. Damon Kiquisol FreeCEC · Traditional | 07/27/1978SE |
| K780207 | Liquisol Digoxin Ria Test KitDON · Traditional | 02/23/1978SE |
| K770918 | Liqui Sol T4 Ria Test KitCDP · Traditional | 06/17/1977SE |
| K770606 | Analyzeo, Plasma, Blood, ColysagraphJPA · Traditional | 05/06/1977SE |
| K761013 | Spinette CentrifugeJQC · Traditional | 11/16/1976SE |
Questions and answers
When was Iec CENTRA-7 Centrifuge Model 2362 cleared by the FDA?
Iec CENTRA-7 Centrifuge Model 2362 (K782124) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 61 days after the submission was received.
What is the product code of K782124?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.