TDXR Fetal Lung Maturity
FDA 510(k) K871593 · Abbott Laboratories
510(k) numberK871593
Submission
- Device name
- TDXR Fetal Lung Maturity
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 24, 1987
- Decision date
- July 20, 1987
- 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 |
| 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 |
| K790798 | Fetal Maturity Test ProcedureJHG · Traditional | Helena Laboratories | 06/05/1979SE |
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Questions and answers
When was TDXR Fetal Lung Maturity cleared by the FDA?
TDXR Fetal Lung Maturity (K871593) received a 510(k) decision of Substantially Equivalent on July 20, 1987, 87 days after the submission was received.
What is the product code of K871593?
The FDA product code is JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio, a Class II (moderate risk) device regulated under 21 CFR 862.1455.