Parainfluenza Type 3 Ifa Test Kit for Anti. Detect
FDA 510(k) K884193 · Baxter Diagnostics, Inc.
510(k) numberK884193
Submission
- Device name
- Parainfluenza Type 3 Ifa Test Kit for Anti. Detect
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- October 6, 1988
- Decision date
- November 22, 1988
- 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 |
| 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 |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · 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 |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Parainfluenza Type 3 Ifa Test Kit for Anti. Detect cleared by the FDA?
Parainfluenza Type 3 Ifa Test Kit for Anti. Detect (K884193) received a 510(k) decision of Substantially Equivalent on November 22, 1988, 47 days after the submission was received.
What is the product code of K884193?
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.