Rubeola Igg Clin-Elisa Test System, Cat. #4600
FDA 510(k) K891990 · Clinical Sciences, Inc.
510(k) numberK891990
Submission
- Device name
- Rubeola Igg Clin-Elisa Test System, Cat. #4600
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- March 28, 1989
- Decision date
- June 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Specialty
- Microbiology
The qualitative detection of measles specific IgG antibodies in serum or plasma.
Other 510(k)s with product code LJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974552 | Diamedix Is-Measles Igg Test SystemLJB · Traditional | Diamedix Corp. | 01/28/1998SE |
| K971620 | Quanta Lite Rubeola (Measles) IggLJB · Traditional | Inova Diagnostics, Inc. | 07/22/1997SE |
| K922335 | Bartels Rubeola Igm EiaLJB · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K922330 | Bartels Rubeola Igg EiaLJB · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K910290 | Viratest-Dia(Tm) Measles (Rubeola)LJB · Traditional | Virus Reference Laboratory, Inc. | 03/18/1992SE |
| K904083 | Rubeola Igm Elisa TestLJB · Traditional | Gull Laboratories, Inc. | 01/03/1991SE |
| K903961 | Measles Igg MicroassayLJB · Traditional | Diamedix Corp. | 12/28/1990SE |
| K904854 | Rubeola Igg Elisa TestLJB · Traditional | Gull Laboratories, Inc. | 12/04/1990SE |
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | Electro-Nucleonics Laboratories, Inc. | 02/24/1988SE |
| K821762 | Measelisa Test KitLJB · Traditional | M.A. Bioproducts | 07/30/1982SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K900688 | Varicella Zoster Igg Clin-Elisa Test KitLFY · Traditional | 05/15/1990SE |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | 07/14/1989SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | 07/14/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | 05/11/1989SE |
| K874594 | Toxoplasma Igm Clin-Elisa(Tm) Cat # 5560LGD · Traditional | 03/07/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | 01/11/1988SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | 07/14/1986SE |
| K860773 | Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560LGD · Traditional | 05/23/1986SE |
| K854666 | Cytomegalovirus (CMV) Elisa Test Sys. Cat. NO:4530GQI · Traditional | 02/05/1986SE |
Questions and answers
When was Rubeola Igg Clin-Elisa Test System, Cat. #4600 cleared by the FDA?
Rubeola Igg Clin-Elisa Test System, Cat. #4600 (K891990) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 79 days after the submission was received.
What is the product code of K891990?
The FDA product code is LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a Class I (low risk) device regulated under 21 CFR 866.3520.