510(k) K834616
- Device
- AMNIO STAT-FLM AGGLUTINATION TEST
- Applicant
- HANA BIOLOGICS, INC.
- 510(k) number
- K834616
- Product code
- JHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-25
- Date received
- 1983-12-14
- Regulation
- 862.1455
- Classification name
- Chromatographic Separation, Lecithin/sphingomyelin Ratio
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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 |
| K871593 | TDXR FETAL LUNG MATURITY | Abbott Laboratories | 1987-07-20 |
| 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 |
Legacy Summary#
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FDA Review#
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