510(k) K871593
- Device
- Tdxr Fetal Lung Maturity
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K871593
- Product code
- JHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-20
- Date received
- 1987-04-24
- Regulation
- 862.1455
- Classification name
- Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ZORC
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061549 | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | 2006-10-18 |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | Hana Biologics, Inc. | 1984-05-25 |
| K822150 | AMNISTAT-FLM | Hana Biologics, Inc. | 1982-10-21 |
| K813216 | SECURE FDI TEST KIT | Beckman Instruments, Inc. | 1981-12-17 |
| K811588 | HELENA FETAL-TEK 200 METHOD | Helena Laboratories | 1981-06-25 |
| K790798 | FETAL MATURITY TEST PROCEDURE | Helena Laboratories | 1979-06-05 |