Aft TM System Antismooth Muscle Antibody
FDA 510(k) K800820 · Calbiochem-Behring Corp.
510(k) numberK800820
Submission
- Device name
- Aft TM System Antismooth Muscle Antibody
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- April 11, 1980
- Decision date
- April 24, 1980
- 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 |
| K800228 | Immunop. Antismooth Muscle Antibody KitDBE · Traditional | Clinical Sciences, Inc. | 02/21/1980SE |
| K790430 | Medica Ii-F-Asma Test KitDBE · Traditional | Medica Corp. | 04/23/1979SE |
| 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 |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Aft TM System Antismooth Muscle Antibody cleared by the FDA?
Aft TM System Antismooth Muscle Antibody (K800820) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 13 days after the submission was received.
What is the product code of K800820?
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.