Test, (Ivdp) Smoothmuscle Antibody
FDA 510(k) K760156 · Zeus Scientific, Inc.
510(k) numberK760156
Submission
- Device name
- Test, (Ivdp) Smoothmuscle Antibody
- Applicant
- Zeus Scientific, Inc.
Mchenry, IL, US - Received
- July 2, 1976
- Decision date
- July 20, 1976
- 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 |
| K790430 | Medica Ii-F-Asma Test KitDBE · Traditional | Medica Corp. | 04/23/1979SE |
| K771155 | Anti-MitochondrialDBE · Traditional | Meloy Laboratories, Inc. | 08/04/1977SE |
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Questions and answers
When was Test, (Ivdp) Smoothmuscle Antibody cleared by the FDA?
Test, (Ivdp) Smoothmuscle Antibody (K760156) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 18 days after the submission was received.
What is the product code of K760156?
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.