Antismooth Muscle Antibody Test Sys
FDA 510(k) K810983 · Immuno-Products Industries
510(k) numberK810983
Submission
- Device name
- Antismooth Muscle Antibody Test Sys
- Applicant
- Immuno-Products Industries
Mchenry, IL, US - Received
- April 13, 1981
- Decision date
- May 1, 1981
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K853122 | Immuno-Prod Ind Fluore Trepone Antibody AbsorpedGMS · Traditional | 09/19/1985SE |
| K852231 | ANA/LITE-HEP-2 Test SystemLJM · Traditional | 07/10/1985SE |
| K852230 | Ana/Lite-Rl Test SystemLJM · Traditional | 07/10/1985SE |
| K843613 | Fluorescent Treponemel Antibody-AbsorbGMS · Traditional | 10/31/1984SE |
| K831054 | Antinuclear Antibody Tissue Culture SubDHN · Traditional | 04/27/1983SE |
| K830652 | Anti N Dna-HcpKTL · Traditional | 03/24/1983SE |
| K821576 | Antinuclear Antibody Screen FlourescDBL · Traditional | 06/10/1982SE |
| K810985 | Antinuclear Antibody ImmunofluorescentDHN · Traditional | 05/01/1981SE |
| K810984 | Antimitochondrial Immunofluorescent TestDBM · Traditional | 05/01/1981SE |
| K810982 | Antithyroid Antibody ImmunofluorescentJZO · Traditional | 05/01/1981SE |
Questions and answers
When was Antismooth Muscle Antibody Test Sys cleared by the FDA?
Antismooth Muscle Antibody Test Sys (K810983) received a 510(k) decision of Substantially Equivalent on May 1, 1981, 18 days after the submission was received.
What is the product code of K810983?
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.