Lelective Kinetic SYSTEM-60
FDA 510(k) K780464 · Hycel, Inc.
510(k) numberK780464
Submission
- Device name
- Lelective Kinetic SYSTEM-60
- Applicant
- Hycel, Inc.
Mchenry, IL, US - Received
- March 22, 1978
- Decision date
- May 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K790335 | Hycel MJJF · Traditional | 02/27/1979SE |
| 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 |
| K780262 | Direct Urea Nitrogen TestCDW · Traditional | 04/05/1978SE |
Questions and answers
When was Lelective Kinetic SYSTEM-60 cleared by the FDA?
Lelective Kinetic SYSTEM-60 (K780464) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 42 days after the submission was received.
What is the product code of K780464?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.