Qms(Tm) - Theophylline
FDA 510(k) K885263 · Seradyn, Inc.
510(k) numberK885263
Submission
- Device name
- Qms(Tm) - Theophylline
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- December 23, 1988
- Decision date
- March 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQX – Nephelometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962294 | Immage Immunochemistry SystemJQX · Traditional | Beckman Instruments, Inc. | 08/21/1996SE |
| K922273 | Array(R) 360JQX · Traditional | Beckman Instruments, Inc. | 08/19/1992SE |
| K851253 | TDX Analyzer W/Nephelometry CarouselJQX · Traditional | Abbott Laboratories | 04/30/1985SE |
| K851234 | A-Just Turbidity MeterJQX · Traditional | Abbott Laboratories | 04/29/1985SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | J.T. Baker Chemical Co. | 07/21/1980SE |
| K801089 | J.T. Baker NephelometerJQX · Traditional | J.T. Baker Chemical Co. | 05/28/1980SE |
| K792045 | Biovation NephelometerJQX · Traditional | Biovation, Inc. | 10/30/1979SE |
| K790103 | Nephelometer, MIC-2000 LaserJQX · Traditional | Dynatech Corp. | 03/12/1979SE |
| K781554 | RAD-291JQX · Traditional | Organon, Inc. | 10/11/1978SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | Biovation, Inc. | 10/03/1978SE |
More from Biovation, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K062204 | Architect Cortisol AssayJFT · Traditional | 09/22/2006SE |
| K060998 | QMS TobramycinLCR · Traditional | 07/21/2006SE |
| K060709 | Multigent GentamicinLCD · Traditional | 06/15/2006SE |
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | 12/23/2005SE |
| K051211 | QMS Zonisamide Reagents, Calibrators and ControlsNWM · Traditional | 11/18/2005SE |
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | 11/01/2005SE |
| K050419 | QMS VancomycinLEH · Traditional | 04/01/2005SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | 11/03/2004SE |
Questions and answers
When was Qms(Tm) - Theophylline cleared by the FDA?
Qms(Tm) - Theophylline (K885263) received a 510(k) decision of Substantially Equivalent on March 28, 1989, 95 days after the submission was received.
What is the product code of K885263?
The FDA product code is JQX – Nephelometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2700.