Quantitative Assay for Det. of Igg Igm Anti-Dsdna
FDA 510(k) K893896 · Biostar Medical Products, Inc.
510(k) numberK893896
Submission
- Device name
- Quantitative Assay for Det. of Igg Igm Anti-Dsdna
- Applicant
- Biostar Medical Products, Inc.
Arlington, VA, US - Received
- May 30, 1989
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | Immuno Concepts, N.A. , Ltd. | 05/12/2003SE |
| K024232 | Liquichek Anti-Ss-B Control, Positive, Catalog #113LKJ · Traditional | Bio-Rad | 01/17/2003SE |
| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | Bio-Rad | 01/17/2003SE |
More from Bio-Rad
| 510(k) | Device | Decision |
|---|---|---|
| K893897 | Semi-Quantitative Assay for Det. of Igg and IgmLKJ · Traditional | 06/23/1989SE |
| K863238 | Reads RF Test Kit for Igm Rheumatoid FactorDHR · Traditional | 10/08/1986SE |
| K861499 | Biostar* Reads* Immune Complex Assay KitDAK · Traditional | 06/20/1986SE |
| K853697 | Biostar Re-A-Ds Immune Complex Assay KitDAK · Traditional | 12/16/1985SE |
Questions and answers
When was Quantitative Assay for Det. of Igg Igm Anti-Dsdna cleared by the FDA?
Quantitative Assay for Det. of Igg Igm Anti-Dsdna (K893896) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 45 days after the submission was received.
What is the product code of K893896?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.