Measelisa Test Kit
FDA 510(k) K821762 · M.A. Bioproducts
510(k) numberK821762
Submission
- Device name
- Measelisa Test Kit
- Applicant
- M.A. Bioproducts
Walker, MI, US - Received
- June 15, 1982
- Decision date
- July 30, 1982
- 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 |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | Clinical Sciences, Inc. | 06/15/1989SE |
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | Electro-Nucleonics Laboratories, Inc. | 02/24/1988SE |
More from Electro-Nucleonics Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K823804 | Mycoplasmelisa Test KitLJZ · Traditional | 05/25/1983SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | 05/13/1983SE |
| K830615 | Cytomegelisa StatLFZ · Traditional | 05/09/1983SE |
| K823805 | Varicelisa Test KitLFY · Traditional | 05/05/1983SE |
| K821967 | Chlamydelisa Test KitLJC · Traditional | 08/03/1982SE |
| K813221 | Toxoelisa Test KitLGD · Traditional | 01/26/1982SE |
| K812531 | Cell Culture ReagentsKIT · Traditional | 10/23/1981SE |
| K812123 | Cytomegelisa Test Kit · Traditional | 09/23/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | 12/18/1980SE |
Questions and answers
When was Measelisa Test Kit cleared by the FDA?
Measelisa Test Kit (K821762) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 45 days after the submission was received.
What is the product code of K821762?
The FDA product code is LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a Class I (low risk) device regulated under 21 CFR 866.3520.