Revolution Radial Immunodiffusion Plate
FDA 510(k) K831811 · Calbiochem-Behring Corp.
510(k) numberK831811
Submission
- Device name
- Revolution Radial Immunodiffusion Plate
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- June 6, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZQ – Plates And Equipment, Radial Immunodiffusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4800
- Specialty
- Immunology
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| K792699 | Ouchterlony Agar PlatesJZQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K790646 | Helena Quiplate SystemJZQ · Traditional | Helena Laboratories | 05/23/1979SE |
| K770548 | Immunoplate III Radio ImmunodiffusionJZQ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/15/1977SE |
| K761311 | Accraassay Rid KitsJZQ · Traditional | Miles Laboratories, Inc. | 12/30/1976SE |
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Questions and answers
When was Revolution Radial Immunodiffusion Plate cleared by the FDA?
Revolution Radial Immunodiffusion Plate (K831811) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 52 days after the submission was received.
What is the product code of K831811?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.