Medica Ii-F-Asma Test Kit
FDA 510(k) K790430 · Medica Corp.
510(k) numberK790430
Submission
- Device name
- Medica Ii-F-Asma Test Kit
- Applicant
- Medica Corp.
Mchenry, IL, US - Received
- March 2, 1979
- Decision date
- April 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBE – Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5120
- Specialty
- Immunology
Other 510(k)s with product code DBE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810983 | Antismooth Muscle Antibody Test SysDBE · Traditional | Immuno-Products Industries | 05/01/1981SE |
| K800820 | Aft TM System Antismooth Muscle AntibodyDBE · Traditional | Calbiochem-Behring Corp. | 04/24/1980SE |
| K800228 | Immunop. Antismooth Muscle Antibody KitDBE · Traditional | Clinical Sciences, Inc. | 02/21/1980SE |
| K771155 | Anti-MitochondrialDBE · Traditional | Meloy Laboratories, Inc. | 08/04/1977SE |
| K760156 | Test, (Ivdp) Smoothmuscle AntibodyDBE · Traditional | Zeus Scientific, Inc. | 07/20/1976SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220328 | EasyStat 300CGA · Traditional | 07/26/2024SE |
| K220396 | EasyStat 300CEM · Traditional | 09/26/2023SE |
| K211559 | EasyStat 300CHL · Traditional | 01/27/2023SE |
| K152327 | EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional | 12/01/2016SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | 05/13/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | 05/15/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | 03/01/2013SE |
| K120497 | Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialLCP · Traditional | 05/14/2012SE |
| K111363 | PPX Reagent, PPX Calibrators, PPX QC MaterialJXN · Traditional | 12/06/2011SE |
| K111005 | Ethanol Reagent, Ethanol Calibrator, Ethanol QC MaterialDIC · Traditional | 11/15/2011SE |
Questions and answers
When was Medica Ii-F-Asma Test Kit cleared by the FDA?
Medica Ii-F-Asma Test Kit (K790430) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 52 days after the submission was received.
What is the product code of K790430?
The FDA product code is DBE – Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5120.