510(k) K061549
- Device
- AMNIOSTAT-FLM-PG
- Applicant
- Irvine Scientific Sales Co., Inc.
- 510(k) number
- K061549
- Product code
- JHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-18
- Date received
- 2006-06-05
- Regulation
- 862.1455
- Classification name
- Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- WENDELL LEE, PHARM. D
- Address
- 2511 Daimler St. Santa Ana CA US 92705 92705
Source Documents#
Other 510(k) Records For Product Code JHG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871593 | TDXR FETAL LUNG MATURITY | Abbott Laboratories | 1987-07-20 |
| 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 |