Alexander Manufacturing Rechargeable Battery (M1/T)
FDA 510(k) K970799 · Alexander Mfg. Co.
510(k) numberK970799
Submission
- Device name
- Alexander Manufacturing Rechargeable Battery (M1/T)
- Applicant
- Alexander Mfg. Co.
Mason City, IA, US - Received
- March 4, 1997
- Decision date
- May 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982896 | Alexander Manufacturing Co. Rechargeable Battery Part Number LP9LDD · Traditional | 10/21/1998ST |
| K981776 | Alexander Manufacturing Co. Battery Part Number MC146XFRN · Traditional | 08/03/1998SE |
| K981728 | Alexander Manufacturing Co. Battery Part Number H134BZQ · Traditional | 06/26/1998ST |
| K980224 | Alexander Manufacturing Co. Rechargeable Battery Part Number MS822MOQ · Traditional | 04/02/1998SE |
| K974061 | Rechargeable Battery Part Number GL825-200DXN · Traditional | 01/16/1998SE |
| K973851 | Alexander Manufacturing Co. Rechargeable Battery #M12/630FRN · Traditional | 01/05/1998SE |
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007HFO · Traditional | 11/12/1997SE |
| K972746 | Alexander Manufacturing Co. Rechargeable Battery Part Number LP6/100DPS · Traditional | 10/21/1997SE |
| K972780 | Alexander Manufacturing Co. Rechargeable Battery Part Number GL625MRZ · Traditional | 10/20/1997SE |
| K972779 | Alexander Manufacturing Co. Rechargeable Battery Part Number MS3030-PMRZ · Traditional | 10/20/1997SE |
Questions and answers
When was Alexander Manufacturing Rechargeable Battery (M1/T) cleared by the FDA?
Alexander Manufacturing Rechargeable Battery (M1/T) (K970799) received a 510(k) decision of Substantially Equivalent on May 14, 1997, 71 days after the submission was received.
What is the product code of K970799?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.