Synelisa Parietal Cell Antibodies
FDA 510(k) K930422 · Elias U.S.A., Inc.
510(k) numberK930422
Submission
- Device name
- Synelisa Parietal Cell Antibodies
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- January 26, 1993
- Decision date
- August 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBJ – Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5110
- Specialty
- Immunology
Other 510(k)s with product code DBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K790759 | Iif-Apca Test KitDBJ · Traditional | Medica Corp. | 07/30/1979SE |
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| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
Questions and answers
When was Synelisa Parietal Cell Antibodies cleared by the FDA?
Synelisa Parietal Cell Antibodies (K930422) received a 510(k) decision of Substantially Equivalent on August 3, 1993, 189 days after the submission was received.
What is the product code of K930422?
The FDA product code is DBJ – Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5110.