Hy-Tec/Manual Autoimmune Kit for Mitochondria
FDA 510(k) K962452 · Hycor Biomedical, Inc.
510(k) numberK962452
Submission
- Device name
- Hy-Tec/Manual Autoimmune Kit for Mitochondria
- Applicant
- Hycor Biomedical, Inc.
Garden Grove, CA, US - Received
- June 18, 1996
- Decision date
- November 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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|---|---|---|---|
| K181556 | EliA M2 ImmunoassayDBM · Traditional | Phadia AB | 07/13/2018SE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…DBM · Traditional | Inova Diagnostics, Inc. | 09/05/2017SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | Immco Diagnostics, Inc. | 08/08/2017SE |
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | Phadia US, Inc. | 02/13/2015SE |
| K092736 | Euroimmun ANTI-M2-3E Elisa (Igg)DBM · Traditional | Euroimmun Us, Inc. | 09/02/2010SE |
| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | Rhigene, Inc. | 09/26/2003SE |
| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | The Binding Site, Ltd. | 03/24/2003SE |
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | Trace Scientific , Ltd. | 09/17/1998SE |
| K971909 | Virgo Ama Elisa KitDBM · Traditional | Hemagen Diagnostics, Inc. | 06/20/1997SE |
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| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional | 02/18/2022SE |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS…DHB · Traditional | 06/26/2020SE |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002…DHB · Traditional | 07/31/2019SE |
Questions and answers
When was Hy-Tec/Manual Autoimmune Kit for Mitochondria cleared by the FDA?
Hy-Tec/Manual Autoimmune Kit for Mitochondria (K962452) received a 510(k) decision of Substantially Equivalent on November 25, 1996, 160 days after the submission was received.
What is the product code of K962452?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.