(Fpia) Assay Buffer
FDA 510(k) K871486 · Windsor Laboratories, Inc.
510(k) numberK871486
Submission
- Device name
- (Fpia) Assay Buffer
- Applicant
- Windsor Laboratories, Inc.
Garland, TX, US - Received
- April 15, 1987
- Decision date
- May 8, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873281 | Carbamazepine (Fpia) Calibrator KitDLJ · Traditional | 10/28/1987SE |
| K873282 | Carbamazepine Fpia Fluores. Polariza. ImmunoassayKLT · Traditional | 09/22/1987SE |
| K870390 | Phenobarbital (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K870389 | Digoxin (Fpia) Calibrator KitDLJ · Traditional | 04/01/1987SE |
| K864333 | Digoxin Fpia Fluorescence Polarization ImmunoassayKXT · Traditional | 01/05/1987SE |
| K863625 | Phenobarbital-Fpia Fluores. Polar. Immunoassay KitLGQ · Traditional | 11/10/1986SE |
| K863244 | Amikacin (Fpia) Calibrator KitDLJ · Traditional | 08/29/1986SE |
| K862248 | Amikacin Kit (Fpia)LGJ · Traditional | 08/04/1986SE |
| K861891 | Tobramycin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
| K861770 | Phenytoin (Fpia) Calibrator KitJIS · Traditional | 06/25/1986SE |
Questions and answers
When was (Fpia) Assay Buffer cleared by the FDA?
(Fpia) Assay Buffer (K871486) received a 510(k) decision of Substantially Equivalent on May 8, 1987, 23 days after the submission was received.
What is the product code of K871486?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.