Antibody Assay for Detect. of Parainfluenza Type 2
FDA 510(k) K871228 · Microscan Div. Baxter Healthcare Corp.
510(k) numberK871228
Submission
- Device name
- Antibody Assay for Detect. of Parainfluenza Type 2
- 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
- GQS – Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3400
- Specialty
- Microbiology
Other 510(k)s with product code GQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitGQS · Traditional | Diagnostic Hybrids, Inc. | 12/23/2009SE |
| K943557 | ImagenGQS · Traditional | Dako Diagnostics , Ltd. | 01/09/1995SE |
| K905385 | P.I.V. Complement-Fixation (C.F.) AntigenGQS · Traditional | Virion (U.S.), Inc. | 03/21/1991SE |
| K884194 | Parainfluenza Type 1 Ifa Test Kit for Anti. DetectGQS · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K884193 | Parainfluenza Type 3 Ifa Test Kit for Anti. DetectGQS · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K843667 | Parainfluenza 3GQS · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K843665 | Parainfluenza 1GQS · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K802935 | Parainfluenza 1,2, & 3 Antigens & ContrGQS · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, 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 |
| K871230 | Antibody Assay for Detec. of Resp. Syncytial VirusLKT · Traditional | 06/26/1987SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · 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 Detect. of Parainfluenza Type 2 cleared by the FDA?
Antibody Assay for Detect. of Parainfluenza Type 2 (K871228) 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 K871228?
The FDA product code is GQS – Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, a Class I (low risk) device regulated under 21 CFR 866.3400.