Bi-Level Assayed Card. Drug Cont., I,Ii
FDA 510(k) K800357 · Ortho Diagnostics, Inc.
510(k) numberK800357
Submission
- Device name
- Bi-Level Assayed Card. Drug Cont., I,Ii
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- February 20, 1980
- Decision date
- April 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K970517 | Innofluor Topiramate Control SetLAS · Traditional | Oxis Intl., Inc. | 05/12/1997SE |
| K971210 | Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine ControlsLAS · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | 12/04/1978SE |
Questions and answers
When was Bi-Level Assayed Card. Drug Cont., I,Ii cleared by the FDA?
Bi-Level Assayed Card. Drug Cont., I,Ii (K800357) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 56 days after the submission was received.
What is the product code of K800357?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.