Ferritin Serozyme Immunoenzymetric Assay
FDA 510(k) K884683 · Serono-Baker Diagnostics, Inc.
510(k) numberK884683
Submission
- Device name
- Ferritin Serozyme Immunoenzymetric Assay
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- November 8, 1988
- Decision date
- December 27, 1988
- 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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|---|---|---|
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | 11/30/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
Questions and answers
When was Ferritin Serozyme Immunoenzymetric Assay cleared by the FDA?
Ferritin Serozyme Immunoenzymetric Assay (K884683) received a 510(k) decision of Substantially Equivalent on December 27, 1988, 49 days after the submission was received.
What is the product code of K884683?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.