Quik-Sep Hemoglobin F Assay & Control
FDA 510(k) K820630 · Isolab, Inc.
510(k) numberK820630
Submission
- Device name
- Quik-Sep Hemoglobin F Assay & Control
- Applicant
- Isolab, Inc.
Walker, MI, US - Received
- March 8, 1982
- Decision date
- June 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPC – Hemoglobin F Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7455
- Specialty
- Hematology
More from Isolab, Inc.
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|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
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| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Quik-Sep Hemoglobin F Assay & Control cleared by the FDA?
Quik-Sep Hemoglobin F Assay & Control (K820630) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 109 days after the submission was received.
What is the product code of K820630?
The FDA product code is JPC – Hemoglobin F Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7455.