Hycel M
FDA 510(k) K790335 · Hycel, Inc.
510(k) numberK790335
Submission
- Device name
- Hycel M
- Applicant
- Hycel, Inc.
Mchenry, IL, US - Received
- February 21, 1979
- Decision date
- February 27, 1979
- 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
Other 510(k)s with product code JJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052794 | Eti-Max 3000JJF · Traditional | DiaSorin, Inc. | 03/31/2006SE |
| K040332 | Polymedco Spotchem Ez Chemistry AnalyzerJJF · Traditional | Arkray, Inc. | 06/16/2004SE |
| K033734 | Lightcycler Instrument Version 1.2JJF · Traditional | Roche Diagnostics Corp. | 12/17/2003SE |
| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
| K012966 | Roche Cobas Taqman AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 02/01/2002SE |
| 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 |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | 01/26/1979SE |
| K782116 | Ketosteroid Test, HYCEL-17CCY · Traditional | 01/26/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | 01/03/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | 07/27/1978SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | 07/27/1978SE |
| K780464 | Lelective Kinetic SYSTEM-60JJE · Traditional | 05/03/1978SE |
| K780262 | Direct Urea Nitrogen TestCDW · Traditional | 04/05/1978SE |
Questions and answers
When was Hycel M cleared by the FDA?
Hycel M (K790335) received a 510(k) decision of Substantially Equivalent on February 27, 1979, 6 days after the submission was received.
What is the product code of K790335?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.