Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 E
FDA 510(k) K000336 · Rhigene, Inc.
510(k) numberK000336
Submission
- Device name
- Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 E
- Applicant
- Rhigene, Inc.
Des Plaines, IL, US - Received
- February 3, 2000
- Decision date
- June 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NBO – Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code NBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091969 | Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)NBO · Traditional | Euroimmun Us, Inc. | 09/02/2010SE |
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| K022017 | Rhigene MESACUP-2 Test RNP, Model M7741LKO · Traditional | 08/14/2002SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | 07/05/2002SE |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional | 04/11/2002SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | 05/09/2000SE |
| K000752 | Rhigene MESACUP2 Test- RNPLKO · Traditional | 05/09/2000SE |
Questions and answers
When was Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 E cleared by the FDA?
Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 E (K000336) received a 510(k) decision of Substantially Equivalent on June 9, 2000, 127 days after the submission was received.
What is the product code of K000336?
The FDA product code is NBO – Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3), a Class II (moderate risk) device regulated under 21 CFR 866.5660.