Pg-Numeric(Tm)
FDA 510(k) K883411 · Isolab, Inc.
510(k) numberK883411
Submission
- Device name
- Pg-Numeric(Tm)
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- August 15, 1988
- Decision date
- March 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHF – Colorimetric Method, Lecithin/Sphingomyelin Ratio
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1455
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940817 | Tdx(R)/Tdxflx(R) Fetal Lung Maturity IIJHF · Traditional | Abbott Laboratories | 02/08/1995SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| 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 Pg-Numeric(Tm) cleared by the FDA?
Pg-Numeric(Tm) (K883411) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 212 days after the submission was received.
What is the product code of K883411?
The FDA product code is JHF – Colorimetric Method, Lecithin/Sphingomyelin Ratio, a Class II (moderate risk) device regulated under 21 CFR 862.1455.