510(k) K940817
- Device
- Tdx(r)/tdxflx(r) Fetal Lung Maturity Ii
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K940817
- Product code
- JHF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-08
- Date received
- 1994-02-22
- Regulation
- 862.1455
- Classification name
- Colorimetric Method, Lecithin/Sphingomyelin Ratio
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Irene Powers
- Address
- Dept: 09v8 Bldg: Ap5-2 100 Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
Other 510(k) Records For Product Code JHF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883411 | PG-NUMERIC(TM) | Isolab, Inc. | 1989-03-15 |