Ena Test Kit SM & RNP Auto Antibody
FDA 510(k) K831036 · Calbiochem-Behring Corp.
510(k) numberK831036
Submission
- Device name
- Ena Test Kit SM & RNP Auto Antibody
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- March 31, 1983
- Decision date
- April 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
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| 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 |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | 03/11/1981SE |
Questions and answers
When was Ena Test Kit SM & RNP Auto Antibody cleared by the FDA?
Ena Test Kit SM & RNP Auto Antibody (K831036) received a 510(k) decision of Substantially Equivalent on April 27, 1983, 27 days after the submission was received.
What is the product code of K831036?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.