Fetal Maturity Test Procedure
FDA 510(k) K790798 · Helena Laboratories
510(k) numberK790798
Submission
- Device name
- Fetal Maturity Test Procedure
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- April 17, 1979
- Decision date
- June 5, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1455
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061549 | Amniostat-Flm-PgJHG · Traditional | Irvine Scientific Sales Co., Inc. | 10/18/2006SE |
| K871593 | TDXR Fetal Lung MaturityJHG · Traditional | Abbott Laboratories | 07/20/1987SE |
| K834616 | Amnio Stat-Flm Agglutination TestJHG · Traditional | Hana Biologics, Inc. | 05/25/1984SE |
| K822150 | Amnistat-FlmJHG · Traditional | Hana Biologics, Inc. | 10/21/1982SE |
| K813216 | Secure Fdi Test KitJHG · Traditional | Beckman Instruments, Inc. | 12/17/1981SE |
| K811588 | Helena Fetal-Tek 200 MethodJHG · Traditional | Helena Laboratories | 06/25/1981SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K213396 | SPIFE A1AT kitOBZ · Traditional | 10/13/2022SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | 04/19/2022SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | 10/07/2013SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
Questions and answers
When was Fetal Maturity Test Procedure cleared by the FDA?
Fetal Maturity Test Procedure (K790798) received a 510(k) decision of Substantially Equivalent on June 5, 1979, 49 days after the submission was received.
What is the product code of K790798?
The FDA product code is JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio, a Class II (moderate risk) device regulated under 21 CFR 862.1455.