Rubeola Igm Elisa Test
FDA 510(k) K904083 · Gull Laboratories, Inc.
510(k) numberK904083
Submission
- Device name
- Rubeola Igm Elisa Test
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- September 5, 1990
- Decision date
- January 3, 1991
- 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 |
| 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 |
| K821762 | Measelisa Test KitLJB · Traditional | M.A. Bioproducts | 07/30/1982SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Rubeola Igm Elisa Test cleared by the FDA?
Rubeola Igm Elisa Test (K904083) received a 510(k) decision of Substantially Equivalent on January 3, 1991, 120 days after the submission was received.
What is the product code of K904083?
The FDA product code is LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a Class I (low risk) device regulated under 21 CFR 866.3520.