Helena Fetal-Tek 200 Method
FDA 510(k) K811588 · Helena Laboratories
510(k) numberK811588
Submission
- Device name
- Helena Fetal-Tek 200 Method
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- June 8, 1981
- Decision date
- June 25, 1981
- 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 |
| K790798 | Fetal Maturity Test ProcedureJHG · Traditional | Helena Laboratories | 06/05/1979SE |
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Questions and answers
When was Helena Fetal-Tek 200 Method cleared by the FDA?
Helena Fetal-Tek 200 Method (K811588) received a 510(k) decision of Substantially Equivalent on June 25, 1981, 17 days after the submission was received.
What is the product code of K811588?
The FDA product code is JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio, a Class II (moderate risk) device regulated under 21 CFR 862.1455.