Amnistat-Flm
FDA 510(k) K822150 · Hana Biologics, Inc.
510(k) numberK822150
Submission
- Device name
- Amnistat-Flm
- Applicant
- Hana Biologics, Inc.
Walker, MI, US - Received
- July 22, 1982
- Decision date
- October 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1455
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061549 | Amniostat-Flm-PgJHG · Traditional | Irvine Scientific Sales Co., Inc. | 10/18/2006SE |
| K871593 | TDXR Fetal Lung MaturityJHG · Traditional | Abbott Laboratories | 07/20/1987SE |
| K834616 | Amnio Stat-Flm Agglutination TestJHG · Traditional | Hana Biologics, Inc. | 05/25/1984SE |
| K813216 | Secure Fdi Test KitJHG · Traditional | Beckman Instruments, Inc. | 12/17/1981SE |
| K811588 | Helena Fetal-Tek 200 MethodJHG · Traditional | Helena Laboratories | 06/25/1981SE |
| K790798 | Fetal Maturity Test ProcedureJHG · Traditional | Helena Laboratories | 06/05/1979SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K883682 | Chang Medium (Additional Indications)KIT · Traditional | 09/16/1988SE |
| K855205 | Mycotrim TM VL Triphasic Culture SystemJSI · Traditional | 02/05/1986SE |
| K834616 | Amnio Stat-Flm Agglutination TestJHG · Traditional | 05/25/1984SE |
| K833933 | Ace Color TestKQN · Traditional | 03/23/1984SE |
| K822737 | Mycotrium-RsJSI · Traditional | 12/03/1982SE |
| K822736 | Mycotrium-GuJSI · Traditional | 12/03/1982SE |
| K812820 | Chang MediumKIT · Traditional | 11/10/1981SE |
Questions and answers
When was Amnistat-Flm cleared by the FDA?
Amnistat-Flm (K822150) received a 510(k) decision of Substantially Equivalent on October 21, 1982, 91 days after the submission was received.
What is the product code of K822150?
The FDA product code is JHG – Chromatographic Separation, Lecithin/Sphingomyelin Ratio, a Class II (moderate risk) device regulated under 21 CFR 862.1455.