Rep(R) Immunofix
FDA 510(k) K901805 · Helena Laboratories
510(k) numberK901805
Submission
- Device name
- Rep(R) Immunofix
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 20, 1990
- Decision date
- June 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAH – Gamma Globulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931247 | Titan Gel IMMUNOFIX-9 Cat. No. 3051 and 3067DAH · Traditional | Helena Laboratories | 04/27/1993SE |
| K905149 | Titan GelDAH · Traditional | Helena Laboratories | 01/03/1991SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| K883494 | Technicon DPA-1 Immunoglobulin GDAH · Traditional | Technicon Instruments Corp. | 09/07/1988SE |
| K854944 | TDX Immunoglobulin M Diagnostic KitDAH · Traditional | Abbott Laboratories | 08/27/1986SE |
| K862184 | Dako Ita, Immunoglobulin M (Igm)DAH · Traditional | Dako Corp. | 08/19/1986SE |
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Questions and answers
When was Rep(R) Immunofix cleared by the FDA?
Rep(R) Immunofix (K901805) received a 510(k) decision of Substantially Equivalent on June 6, 1990, 47 days after the submission was received.
What is the product code of K901805?
The FDA product code is DAH – Gamma Globulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.