Antibody Assay for Detec. of Resp. Syncytial Virus
FDA 510(k) K871230 · Microscan Div. Baxter Healthcare Corp.
510(k) numberK871230
Submission
- Device name
- Antibody Assay for Detec. of Resp. Syncytial Virus
- Applicant
- Microscan Div. Baxter Healthcare Corp.
West Sacramento, CA, US - Received
- March 27, 1987
- Decision date
- June 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code LKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | Diagnostic Hybrids, Inc. | 12/23/2008SE |
| K983336 | Pathodx Respiratory Virus Panel Model PKRP1LKT · Traditional | Diagnostic Products Corp. | 03/18/1999SE |
| K943317 | Pathodx Respiratory Syncytial Virus (RSV)LKT · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K942173 | RSV Antigen TestLKT · Traditional | Neogenex | 06/30/1994SE |
| K912842 | Rsv-Mab TestLKT · Traditional | Gull Laboratories, Inc. | 12/09/1991SE |
| K912838 | Bartels Respiratory Syncytial Virus Enzyme ImmunoLKT · Traditional | Baxter Diagnostics, Inc. | 09/27/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | Vitek Systems, Inc. | 09/23/1991SE |
| K894623 | Respiratory Syncytial VirusLKT · Traditional | Bion Ent., Ltd. | 10/16/1989SE |
| K884192 | RSV Ifa Test Kit for Direct Antigen DetectionLKT · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K882687 | Anti-Respiratory Syncytial Virus Antibody TestLKT · Traditional | Gull Laboratories, Inc. | 08/30/1988SE |
More from Gull Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | 06/26/1987SE |
| K871233 | Antibody Assay for Detection of Influenza aGNX · Traditional | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | 06/26/1987SE |
| K871231 | Antibody Assay for Detection of Influenza BGNX · Traditional | 06/26/1987SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · Traditional | 06/26/1987SE |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · Traditional | 06/26/1987SE |
| K870814 | Herpes Simplex Antibody Test for Dect. of HSV 1&2GQL · Traditional | 06/04/1987SE |
| K870074 | Gram Negative and Gram Positive Mic/Combo PanelsJWY · Traditional | 04/14/1987SE |
| K871033 | Rabbit Kidney Culture Cells (First Pass)KIR · Traditional | 03/31/1987SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | 03/17/1987SE |
Questions and answers
When was Antibody Assay for Detec. of Resp. Syncytial Virus cleared by the FDA?
Antibody Assay for Detec. of Resp. Syncytial Virus (K871230) received a 510(k) decision of Substantially Equivalent on June 26, 1987, 91 days after the submission was received.
What is the product code of K871230?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.