Gemstar II System
FDA 510(k) K873617 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK873617
Submission
- Device name
- Gemstar II System
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Columbia, MD, US - Received
- September 8, 1987
- Decision date
- October 19, 1987
- 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 |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
| K853373 | Delta Trol I & IIJJT · Traditional | 08/23/1985SE |
Questions and answers
When was Gemstar II System cleared by the FDA?
Gemstar II System (K873617) received a 510(k) decision of Substantially Equivalent on October 19, 1987, 41 days after the submission was received.
What is the product code of K873617?
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.