Autopak Ferritin Test Delivery Sys
FDA 510(k) K823275 · Micromedic Systems
510(k) numberK823275
Submission
- Device name
- Autopak Ferritin Test Delivery Sys
- Applicant
- Micromedic Systems
Mchenry, IL, US - Received
- November 3, 1982
- Decision date
- December 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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More from Reference Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923643 | MedicoolILO · Traditional | 03/31/1993SE |
| K872309 | Micromedic Combostat Lh/Fsh KitCGJ · Traditional | 07/31/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | 04/01/1987SE |
| K862206 | Taurus (TM) Automatic Liquid Scintillation CounterJJJ · Traditional | 08/04/1986SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | 07/14/1986SE |
| K861262 | MMS T3 UptakeKHQ · Traditional | 05/23/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | 04/24/1986SE |
Questions and answers
When was Autopak Ferritin Test Delivery Sys cleared by the FDA?
Autopak Ferritin Test Delivery Sys (K823275) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 30 days after the submission was received.
What is the product code of K823275?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.