Bartels Rubeola Igm Eia
FDA 510(k) K922335 · Baxter Diagnostics, Inc.
510(k) numberK922335
Submission
- Device name
- Bartels Rubeola Igm Eia
- Applicant
- Baxter Diagnostics, Inc.
Bellevue, WA, US - Received
- May 13, 1992
- Decision date
- September 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K821762 | Measelisa Test KitLJB · Traditional | M.A. Bioproducts | 07/30/1982SE |
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Questions and answers
When was Bartels Rubeola Igm Eia cleared by the FDA?
Bartels Rubeola Igm Eia (K922335) received a 510(k) decision of Substantially Equivalent on September 2, 1992, 112 days after the submission was received.
What is the product code of K922335?
The FDA product code is LJB – Enzyme Linked Immunoabsorbent Assay, Rubeola Igg, a Class I (low risk) device regulated under 21 CFR 866.3520.