Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova Co-Oximeter THB Calibrator
FDA 510(k) K993104 · Nova Biomedical Corp.
510(k) numberK993104
Submission
- Device name
- Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova Co-Oximeter THB Calibrator
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- September 16, 1999
- Decision date
- December 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GLY – Oximeter To Measure Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code GLY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050014 | Hemonir TMGLY · Traditional | Nir Diagnostics, Inc. | 05/05/2005SE |
| K955013 | Nova Co-Oximeter AnalyzerGLY · Traditional | Nova Biomedical Corp. | 04/25/1996SE |
| K952725 | MulticheckGLY · Traditional | Radiometer America, Inc. | 02/20/1996SE |
| K895466 | Avl Model 912 Co-OxyliteGLY · Traditional | Avl Scientific Corp. | 11/06/1989SE |
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Questions and answers
When was Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova Co-Oximeter THB Calibrator cleared by the FDA?
Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova Co-Oximeter THB Calibrator (K993104) received a 510(k) decision of Substantially Equivalent on December 2, 1999, 77 days after the submission was received.
What is the product code of K993104?
The FDA product code is GLY – Oximeter To Measure Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7500.