FDA Product Code
FDA Product Code JHG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1455
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061549 | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | 2006-10-18 | Traditional | PDF ↗ |
| K871593 | TDXR FETAL LUNG MATURITY | Abbott Laboratories | 1987-07-20 | Traditional | PDF ↗ |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | Hana Biologics, Inc. | 1984-05-25 | Traditional | PDF ↗ |
| K822150 | AMNISTAT-FLM | Hana Biologics, Inc. | 1982-10-21 | Traditional | PDF ↗ |
| K813216 | SECURE FDI TEST KIT | Beckman Instruments, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K811588 | HELENA FETAL-TEK 200 METHOD | Helena Laboratories | 1981-06-25 | Traditional | PDF ↗ |
| K790798 | FETAL MATURITY TEST PROCEDURE | Helena Laboratories | 1979-06-05 | Traditional | PDF ↗ |
Product code JHG · Class II · Clinical Chemistry. Data: openFDA.